Summary The Clinical Data Operations Lead is part of the data42 Clinical Data Pipeline team and is responsible for leading all data operations related to the Clinical Data assets for data42 and will report to the Clinical Data Pipeline Owner. A key aspect of the program is to centralize all clinical data collected across Novartis clinical studies to enable secondary research involving clinical trials data, including clinical raw and ready-to-be analyzed data of the clinical databases (EDC, lab and 3rd party data). The position is a key collaborator with other data42 teams. Ensures that clinical data are ingested, mapped and harmonized according to CDISC SDTM/ADaM standards, curated, medically recoded (WHODrug/MedDRA) and anonymized according to Good Clinical Data Management Principles efficiently with timely and high quality deliverables as per data42 user needs. To do so, the team lead will oversee all Subject Matter Expert (SME) squads operational data activities and will guarantee their excellence in execution across the Clinical Data Pipeline and check their achievement with business needs. Team Lead will onboard, train and ensure business continuity of the squads and will maintain/define use case portfolio lifecycle by applying Agile project management framework. Create and maintain processes and documentation. Create KPIs/Metrics/reports showing efficiency and quality improvements in the field of clinical data operations and will report them to Clinical Data Pipeline Owner on a regular basis. About the Role Major accountabilities: Lead Clinical Data operations for data42 across the Clinical Data Pipeline and be responsible for overall data delivery of the team aligned with use case needs and Clinical Data Pipelines releases. Act as functional manager for local associates including providing supervision and advice to the SME squads on functional expertise and processes. Make data transformation/standardization decisions/recommendations as required and translate use case needs into data operations. Ensure all practices are aligned with Good Clinical Data Management Principles related to Clinical Data Pooling activities Communication with stakeholders, ensuring the clinical data operations and reporting meets quality requirements and on-time delivery. Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical aspects (timelines, scope, resource plan) e.g. as Clinical Data Operations representative in project-level team. Comply with company, department and industry standards (e.g. CDISC, NCI) and processes (GCDMP, ICH-GCP), assess and clarify additional requirements at project-level. Ensure timely and quality data operations and validation of datasets and outputs. Responsible for quality control and audit readiness of all assigned data operations and data release deliverables involving clinical pipeline. Maintain up-to-date knowledge of Clinical Pipeline software and methodologies as well as industry requirements, attend functional meetings and trainings. As assigned, act as SME or contribute to process improvement project initiatives with a focus on anonymization and reporting procedures. Act as Clinical Data Management expert in problem-solving aspects. Maintain use cases portfolio involving data operations during their lifecycle. Recruiting, working with external provider of contractors. KANBAN Agile methodology application Key performance indicators: Achievement of goals with high quality and timeliness of clinical data operations deliverables and contributions as assessed by the Clinical Data Pipeline Owner, internal and external customers. Adequate representation of the clinical data operations function as Clinical Data Operations Lead. Effectiveness of communication and team behaviors as assessed by the team members. Collaboration with other data42 product teams Ability and effectiveness in training, mentoring and coordinating internal and external analysts assigned to the same project as assessed by the functional/operational manager. Job Dimensions: Number of associates: Coordination of 5+ internal or external data managers. Acts as a functional manager locally for associates. Impact on the organization: Successful delivery of assigned projects: Timely, high quality and efficiently produced Clinical Golden tables Innovative solutions and improvements to support timely and efficient Clinical golden data deliverables High quality and impactful work product to support the data42 Clinical Data Pipeline team Efficient team organization and environment Minimum Requirements: Education: BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field Work Experience: Ideally 7+years in a clinical data management and /or warehousing role or related experience within the pharmaceutical, healthcare, supporting clinical trials/ or in pharmaceutical industry Strong understanding of data management methods. Provides input to Data Management strategy. Experience as Data Management lead for several studies or project-level activities, including coordination of team of internal or external programmers, ability to transfer own knowledge to others. Good knowledge of industry standards including CDISC data structures and WHODrug/MedDRA dictionaries as well as a solid understanding of the development and use of standard programs Advanced understanding of regulatory requirements relevant to Clinical Data Management (e.g. GCP, study procedures). Knowledge of Agile KANBAN Framework Passionate and deeply knowledgeable about data management, data anonymization and clinical data structures Proven communications and negotiation skills, ability to work well with others globally and influence Established project management skills with a proven track record of leading and/or collaborating with teams in complex global matrix structures and business models. Some people management skills are required in this team lead role. Proven record of at least managing team members. Collaboration / teamwork Ideally AI/ML basic knowledge. Languages : Fluent English (Oral and Written) Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Division Biomedical Research Business Unit Pharma Research Location India Site Hyderabad (Office) Company / Legal Entity IN10 (FCRS = IN010) Novartis Healthcare Private Limited Functional Area Research & Development Job Type Full time Employment Type Regular Shift Work No - Rewrite
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About the Role:
The Clinical Data Operations Lead is an integral part of the data42 Clinical Data Pipeline team at Novartis, responsible for overseeing all data operations related to clinical data assets. This role involves centralizing clinical data collected across Novartis clinical studies to enable secondary research, including the handling of raw and analyzable clinical data from various databases (EDC, lab, and third-party data). Reporting to the Clinical Data Pipeline Owner, the Lead will collaborate with other data42 teams to ensure data ingestion, mapping, and harmonization according to CDISC SDTM/ADaM standards. The data will be curated, medically recoded (WHODrug/MedDRA), and anonymized following Good Clinical Data Management Principles, ensuring timely and high-quality deliverables.
Key Responsibilities:
Key Performance Indicators:
Impact on the Organization:
Minimum Requirements:
Languages:
Why Novartis:
Join a community of smart, passionate individuals at Novartis, working together to achieve breakthroughs that change patients' lives. Learn more and consider joining the Novartis Network for future career opportunities.
Location: Hyderabad, India
Division: Biomedical Research
Business Unit: Pharma Research
Company/Legal Entity: IN10 (FCRS = IN010) Novartis Healthcare Private Limited
Functional Area: Research & Development
Job Type: Full-time, Regular
Shift Work: No
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Job Type: Full-Time Job Responsibilities: Job Overview Manage Safety staff responsible delivering services in Safety Operations under the guidance of senior management. May contribute to Global initiatives. Work in close collaboration with Senior Management and other relevant stakeholders supporting the achievement of local and global deliverables and metrics. Exp: Bachelor's degree in life sciences or related field and up to 6 years of relevant experience, inclusive of up to 4 years of PV experience and up to 2 years of people management experience. Essential Functions • Implement and support operational decisions as determined and instructed by senior management. May contribute and assist in global initiatives e.g. Change Management • Subject Matter Expert (SME) Committees • SOP Review Committees • Retention, Engagement, training, processes etc. • Assist in the implementation for measuring and improving employee engagement local and/or global actions. Maintain open and regular communication with direct reports to ensure a supportive working environment. • Supervise Safety Operations staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work • performance appraisal and professional development guidance • rewarding and disciplining employees • addressing employee relations issues • resolving problems and absence management. Approve actions on human resources matters. • Support the management on project resource assignments, staff hiring and staff terminations in collaborations with operations specialist managers. - Assists with staff training • professional and career development. • Work closely with operations managers to address problem areas, work scheduling for current and projected projects, and projected peak workloads. Monitor, assess and report utilization of staff. Identify and implement solutions to address poor utilization. • Ensure direct reports are cross trained on Safety service offering as applicable • monitor and develop training plans • identify training and development needs of staff in collaboration with Training team and Safety Management. • Lead and encourage direct reports in continuous improvement of department work processes, procedures and infrastructure. Instruct and lead direct reports in efficient management of project budgets through effective timesheet reporting. Work closely with operations specialist managers. • Monitor and ensure that project processes and department deliverables meet expected quality, financial and productivity targets. Assist with meeting department utilization and realization targets. • Ensure timely movement of project work through the process steps, in accordance with governing SOPs, ICH/FDA regulations and guidelines, work instructions and client expectations. • Ensure that staff have been trained on and are following required Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), FDA and ICH guidelines and regulations, Work Instructions and project instructions. • Work with Safety Management constructively in a matrix framework to achieve project and customer deliverables. • Perform other duties as assigned. • Support or Lead change management initiatives • Effectively able to manage People issues • Responsible for ensuring 100% compliance towards people practice and processes Qualifications • Bachelor's Degree Scientific or healthcare discipline or allied life sciences Req • Bachelor's degree in life sciences or related field and up to 6 years of relevant experience, inclusive of up to 4 years of PV experience and up to 2 years of people management experience. Req • or equivalent combination of education, training and experience. Pref • Sound knowledge of Safety service lines. Advanced • willingness to increase knowledge across Safety service lines and develop new skills. Advanced • Staff management skills, effective leadership, motivational and influencing skills. Advanced • Ability to work on multiple projects and manage competing priorities. Advanced • Ability to mentor and coach. Advanced • Strong presentation, report writing skills and customer focus skills. Advanced • Ability to achieve results through communication and facilitation in a matrix service delivery environment with shared accountabilities. Advanced • Sound judgment, decision-making and problem solving skills. Advanced • Ability to establish and maintain effective working relationships with coworkers, managers and clients. Advanced • Extensive use of telephone and face-to-face communication requiring accurate perception of speech. Advanced • Regular sitting for extended periods of time. Advanced • May require occasional travel. Advanced • Ensure quality of deliverables according to the agreed terms. Advanced • Demonstration of IQVIA core values while doing daily tasks. Advanced • Skill to plan work load based on available capacity and ability to change prioritization based on workload fluctuations. Advanced • Skill to negotiate and work on finding a central ground that is satisfactory to all concerned stake holders - Extensive use of keyboard requiring repetitive motion of fingers. Advanced • Flexibility to operate in shifts. Advanced IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com Kolkata, India
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Location: Kolkata, India
Company: IQVIA
As a Safety Operations Manager at IQVIA, you will lead and manage a team responsible for delivering safety services under the guidance of senior management. Your role involves overseeing day-to-day safety operations, supporting both local and global initiatives, and ensuring compliance with industry regulations and company standards. You will collaborate closely with other teams and stakeholders to achieve project deliverables and metrics, focusing on maintaining high-quality service and operational efficiency.
Key Responsibilities:
Qualifications:
Additional Information:
IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. The company focuses on pushing the boundaries of human and data science to create a healthier world. For more information and to explore career opportunities, visit IQVIA Careers.
Note: Ensure quality of deliverables according to agreed terms, demonstrate IQVIA core values, and possess the flexibility to adapt to workload fluctuations and negotiate satisfactory solutions for all stakeholders.
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Summary: RxLogix Corporation is a niche multinational software company headquartered in Princeton, NJ, USA. We have multiple offices present across US, Europe, Japan, and India. RxLogix’s enterprise software applications are used by world’s Top 10 pharma companies like Merck, Johnson & Johnson, Novartis, etc. We seek passionate engineers to join our development teams at our Noida and Bangalore offices. The ideal candidate is an experienced full stack developer who has worked with Agile methodologies. You will be working on building enterprise class software applications to ensure patient safety around the world. General Purpose: Develop applications based on Microservices architecture. Use of latest technologies including Java, Spring, Spring-Boot, Angular, Hibernate, Grails, Groovy, Kafka, R, Redis, Hazelcast, Bootstrap, jQuery etc. Make use of tools: AWS, GIT, Nginx, Tomcat, Oracle, Jira, Confluence, Jenkins etc. Small cross functional development teams. A high energy team with varied backgrounds and rich technology experience. Creative and fun atmosphere with a focus on getting things done with highest standards of quality. Essential Duties & Responsibilities: Product design and requirement understanding. Full Stack product development. Design visually compelling and easy to use interfaces and components. Develop highly scalable and high-performance enterprise applications for Fortune 100 pharmaceutical companies. Collaborate across teams including subject matter experts to deliver high quality products. Thrive in a fast-paced agile environment with ability to handle change. Minimum Requirements: BE/B.Tech/MCA from recognized institute with good academic score. Must have 3+ years of Java 7/8 programming experience. Must have worked on Spring framework & Hibernate based web-application development experience from scratch. Extensive experience on OOPS and Design patterns. Exposure to relational databases like Oracle, MySQL etc. Experience working with Bootstrap, JavaScript, jQuery & HTML. Must have strong problem solving and troubleshooting skills. Good verbal and written communication skills. Ability to take initiatives and handle multiple priorities. Experience of developing high quality web applications. Should be open to learn and work on new technologies. - Rewrite
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Location: Noida and Bangalore, India
Company: RxLogix Corporation
RxLogix Corporation, a niche multinational software company headquartered in Princeton, NJ, USA, specializes in developing enterprise software applications for the world's top pharmaceutical companies, including Merck, Johnson & Johnson, and Novartis. We are seeking passionate Full Stack Developers to join our dynamic development teams in Noida and Bangalore. The ideal candidates are experienced in working with Agile methodologies and have a strong background in building enterprise-class software applications to ensure global patient safety.
General Purpose:
As a Full Stack Developer at RxLogix, you will:
Key Responsibilities:
Minimum Requirements:
RxLogix offers a creative and fun working atmosphere, emphasizing the highest standards of quality and a commitment to innovation. Join us to be part of a team that is making a significant impact on patient safety worldwide.
Interested candidates can apply by visiting our careers page.
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Company Description RxLogix is a technology-based pharmaceutical company offering advanced data analytics, signal detection, evaluation, signal management, and benefit-risk assessment for Pharmacovigilance and Risk Management professionals. With our PV Surveillance Suite platform, which includes PV Reports, PV Signal, PV Analytics, and PV Datahub, we are dedicated to improving compliance, productivity, and quality for the entire Drug Safety value chain to ensure patient safety. We highly value innovative and bold thinkers entrenched in the world of science, medicine, and technology. Role Description This is a Full-time Jr. Business Analyst role, working onsite at our Miami, FL location. Primary business/functional/application consultant on client/internal projects, providing support in developing business processes, requirements, configuring and testing the application. Essential Duties & Responsibilities: Provides business and technical deliverables with all aspects of client and internal software development and implementation projects, which include: Provide assistance in the business of drug safety and pharmacovigilance. Provide application support on Drug Safety systems. This includes providing expertise on: Business Process (SOP) development, Requirements gathering and documentation, Wireframes and use cases authoring, Application configuration and functional testing (OQ/PQ), Issue resolution, Running workshops and pilots, Data migration/mapping, and System testing and validation Accountable for specific application deliverables such as Requirements Specifications Document, Configuration Specifications Document, Test Scripts etc. Consult on more than one implementation at one time As a business advisor to the project team, the individual is responsible for participating and contributing toward the attainment of group and individual goals by transferring knowledge and providing timely feedback to company as well as the customer Practice development (internal) projects as assigned, to grow the company assets. Minimum Requirements: BA/BS with emphasis on engineering or science or with equivalent practical experience 1 – 3 years of experience in Information Systems SDLC experience Ability to create Requirements, Use Cases, Configuration and Testing documentation Excellent verbal and written communication skills Excellent MS Office Suite skills Preferred Qualifications: Highly desirable to have process design experience. Software application testing/validation experience Experience in SQL Experience in current technologies and platforms including project management tools and database applications. MBA/MS Travel Expectations: 25-50% No Remote Work – Fully On-Site IMPORTANT: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa. - Rewrite
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RxLogix is a technology-driven pharmaceutical company specializing in advanced data analytics, signal detection, evaluation, signal management, and benefit-risk assessment for Pharmacovigilance and Risk Management professionals. Our PV Surveillance Suite platform, including PV Reports, PV Signal, PV Analytics, and PV Datahub, enhances compliance, productivity, and quality across the Drug Safety value chain to ensure patient safety. We value innovative thinkers deeply rooted in science, medicine, and technology.
Position: Jr. Business Analyst
Location: Onsite at our Miami, FL office
Type: Full-Time
As a Jr. Business Analyst at RxLogix, you will be a primary business, functional, and application consultant on client and internal projects. Your role will involve supporting the development of business processes, gathering requirements, configuring applications, and conducting testing.
Essential Duties & Responsibilities:
Minimum Requirements:
Preferred Qualifications:
Travel Expectations:
Note: Applicants must be authorized to work in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa.
If you are passionate about ensuring patient safety and have the required skills, we encourage you to apply and join our innovative team.
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General Purpose: Business/functional/application consultant on client/internal project, leading software product business, functional & application requirement analysis and documentation, supporting business process development, configuration, implementation, testing & validation of software applications. Essential Duties & Responsibilities: Interact with client users and internal product owners to gather and author business, functional & non-functional requirements improvements for software products Running workshops and pilots with clients for product requirement and implementations Application configurations and business process mappings for drug safety and pharmacovigilance clientsIssue / bug prioritization & management in ticketing management system (JIRA) Formal system validation (OQs, PQs and IQs) and other SDLC documentation activities like authoring Test Strategy, Test Plan, Traceability Matrix, Test Summary Report, etc. Minimum Requirements: Bachelor’s degree from a good college like B.Tech., B.IT or similar 5-8 years of total experience in software industry with at least 3 years in business and functional requirements analysis and authoring experience in pharmacovigilance domain. Medium level knowledge of SQL Knowledge of Drug Safety (Pharmacovigilance) domain Knowledge of a leading Drug Safety System like Argus Safety, ArigG, etc. Experience of system validation in Pharmacovigilance or Drug Safety domain Understanding of 21 CFR Part 11 guidelines Self-driven personality, ability, and interest to guide junior team members Demonstrated proficiency in working on multiple projects and deadlines Strong problem solving and troubleshooting skills Good communication, presentation, and documentation skills Preferred Qualifications: Knowledge of periodic/aggregate reporting (PBRER, DSUR, PADER etc.) and signalling Business process mapping experience with clients Experience of working with enterprise software application Working knowledge and experience of Oracle Database, Agile/JIRA, Confluence Travel Expectations: 0-25% - Rewrite
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The role involves acting as a business, functional, and application consultant on client and internal projects. The primary focus is on leading the analysis and documentation of business, functional, and application requirements for software products. This includes supporting business process development, configuration, implementation, and testing & validation of software applications, particularly in the pharmacovigilance domain.
This role is ideal for a detail-oriented professional with a strong background in software development, pharmacovigilance, and system validation, who is keen on ensuring compliance and high standards in the development and implementation of drug safety systems.
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About the role Job Advert Posting ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations. With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well. Responsibilities (Safety): • Review and process serious adverse events, spontaneously reported adverse reactions and/or other medically related information per assigned tasks and study specific procedures • Conducts literature surveillance in the selected database(s) as outlined in the project scope of work and as per established procedures • Provide input and review relevant safety tracking systems for accuracy and quality and assist with maintaining project files • Perform safety review of clinical and diagnostic data for case processing • Assist with generation of regulatory reports as necessary to ensure regulatory compliance. • Liaise with other ICON departments, investigational site, reporter, and/or Sponsor as necessary regarding safety issues • Assist with coordination of interdepartmental activities (e.g. listing review, quality control, quality assurance (audits), miscellaneous project activities) • Responsible for effective and efficient development of the Safety Management Plan, including development of specific processes to assure consistency within the project. • Supports creation of the SAE/AE reconciliation plan and supports SAE reconciliation in accordance with this plan and other project specific guidelines. • Assures consistency of plans with client contract and identifies out of scope activities promptly and accurately. • Serve as Functional Lead on case processing or medical information projects as assigned; coordinates teams of Pharmacovigilance associates on project level and serves as the Pharmacovigilance point of contact for project teams. • Effectively maintains the safety database and corresponding entry guidelines, including assurance of quality of data following established quality control process. • Generates data listings from the safety database and assumes responsibility for accuracy of the data. • Supports analysis and quality control during the generation of Aggregated Safety Reports (e.g. Development Safety Update Report, IND Annual Report, Periodic Safety Update Reports, and other cumulative safety reports). • Supports Safety Scientist in signal detection and risk management activities. • Supports interim data analysis for DMC reviews. • Participates in internal and client project team meetings, including presentation of the safety process at kick-off and investigator meetings. • Reports project status (including monthly metrics) to project/functional management within agreed upon timelines. • Adheres to financial and administrative processes, such as managing project budget and timelines, estimation of resource needs and projected hours. • Proposes solutions for procedural and technical issues. • Supports audits and inspections as required for the assigned projects. • Serves as subject matter experts for case processing and/or medical information tasks in a project team. • Perform other activities as identified and requested by management, including but limited to: • Respond and process medical information inquiries, including inquiries related to adverse events/reactions and product complaints for Clients’ product(s), as per their agreement with ICON. • Assesses reportability of ICSRs based on the project-specific Safety Reporting Assessment sheet. Requirements: Experience in Pharmaceutical/CRO environment At least 3 year of experience in the pharmacovigilance area Excellent verbal and written communication skills Detail-oriented Fluent in written and verbal English Excellent organizational and time management skills Ability to work effectively independently and within a team environment and across global teams. Benefits of Working in ICON: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent. We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours. We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead. But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change. ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. #LI-FP1 #LI-Hybrid - Rewrite
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ICON plc is a global leader in healthcare intelligence and clinical research. We are dedicated to advancing clinical research and providing outsourced services to pharmaceutical, biotechnology, medical device, government, and public health organizations. Our work helps accelerate the development of drugs and devices that save lives and improve quality of life, with patients at the heart of everything we do.
Our greatest asset is our people, who embody our culture and drive our success. At ICON, we are driven by a mission to succeed and a passion for excellence.
At ICON, we prioritize building a culture that rewards high performance and nurtures talent. We offer competitive salary packages, regularly benchmarked against industry standards, and annual bonuses tied to performance goals. Our benefits include health-related offerings for employees and their families, competitive retirement plans, and life assurance, allowing you to plan confidently for the future.
Beyond competitive compensation and benefits, ICON offers an environment that encourages fulfilling your sense of purpose and driving lasting change. We are committed to providing a workplace free of discrimination and harassment, ensuring equal opportunities for all applicants, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
If you need a reasonable accommodation due to a medical condition or disability, please let us know.
#LI-FP1
#LI-Hybrid
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About the role ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations. With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well. Job Summary: • Serve as safety reporting or safety reporting intelligence processor and/or lead for multiple safety reporting or safety reporting intelligence stand-alone projects, providing management support as designated. • Recognize, exemplify, and adhere to ICON's values, which center around our commitment to People, Clients, and Performance. • As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs. • Complete all departmental project activities accurately in accordance with ICON SOPs, Study Specific Procedures, regulatory requirements, and client processes. • Responsible for safety reporting or safety reporting intelligence activities on assigned projects, working in a customer focused approach and an audit and inspection ready mindset. • Demonstrate skills pertaining to client management, safety reporting intelligence, project scope, submission compliance, quality, and budget as designated. Responsibilities (Reporting): • Submission of expedited Serious Adverse Event (SAE) reports, Periodic reports, line listings and applicable safety information to clients, Regulatory Authorities, Ethics Committees, investigators, third party vendors, Partners, and ICON personnel, if required & as agreed with client during study set-up, within project specified timelines. • Release of safety reporting intelligence for expedited and periodic reports, line listings, for Regulatory Authorities, Ethics Committees, and investigators within specified timelines. • Maintain a comprehensive understanding of ICON's safety reporting systems, processes, and conventions, as appropriate. • Maintain a comprehensive understanding of ICON Standard Operating Procedures (SOPs), Working Procedures (WPs), guidance documents and manuals associated with safety reporting. • Perform oversight of assigned projects ensuring all ICON, Sponsor, and regulatory timeframes are met for the reporting of safety information or for the release of global safety reporting intelligence requirements. • Operate in a lead capacity ensuring ownership and accountability of safety reporting activities or safety reporting intelligence on assigned projects. • Ensure completion of all assigned project activities accurately and in accordance with ICON standards, regulatory requirements, and client contractual obligations. • Serve as support to the Safety Reporting Group management in all aspects of departmental activities, including but not limited to quality and compliance metric review, finance tracking and oversight, project resource tracking, client engagement, training oversight and CAPA oversight as designated. • Collaborate with various parties such as project team members, client contacts, investigators, adverse event reporters, and third-party vendors as applicable Build and maintain good relationships across functional units. • Work within multiple databases. Maintenance of project information or Pharmacovigilance intelligence information with timely updates to the project or intelligence databases. • Perform filing and quality control of documents submitted to the eTMF or agreed filing solution ensuring file readiness on assigned projects for audits or inspections. • Prepare for and represent the department in audits and inspections as designated. • Effectively coaches and mentors less experienced associates in all aspects of safety reporting or safety reporting intelligence and other work, as needed. • Implement and coordinate routine project activities, including presentations at client or investigator meetings, responses to client, authorities, and other stakeholders; review of project requirements and maintenance activities; review, escalation of metrics; and budget considerations as assigned. • Participate in client and internal meetings, representing the Safety Reporting department for the assigned projects as designated. • Maintain understanding of applicable therapeutic areas and disease states as required. Requirements: Experience in Pharmaceutical/CRO environment At least 3 year of experience in the pharmacovigilance area Excellent verbal and written communication skills Detail-oriented Fluent in written and verbal English Excellent organizational and time management skills Ability to work effectively independently and within a team environment and across global teams. Benefits of Working in ICON: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent. We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours. We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead. But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change. ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. - Rewrite
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ICON plc is a leading healthcare intelligence and clinical research organization, advancing clinical research from molecule to medicine. We provide outsourced services to pharmaceutical, biotechnology, medical device, government, and public health organizations. Our mission centers around patients, aiming to accelerate the development of drugs and devices that save lives and enhance quality of life.
At ICON, our people are our greatest asset, driving our culture and success. Our team is dedicated to excellence and embodies a mission-driven spirit that ensures we excel in all we do.
At ICON, we prioritize a culture that rewards high performance and nurtures talent. We offer competitive salary packages, regularly benchmarked against industry standards, with annual bonuses tied to performance goals. Our benefits include comprehensive health-related offerings for employees and their families, competitive retirement plans, and life assurance, providing confidence for the future.
Beyond compensation and benefits, ICON offers an environment that encourages you to fulfill your sense of purpose and drive lasting change. We are committed to providing a workplace free of discrimination and harassment, ensuring equal opportunities for all applicants, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
If you need a reasonable accommodation due to a medical condition or disability, please let us know.
#LI-FP1
#LI-Hybrid
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Make a Difference on Your Own Schedule and Terms! Summary The Registered Dietitian is a per diem/PRN position for PCM Trials. A PCM Trials RD will provide nutritional services defined in a clinical trial virtually or in-person for clinical trial participants. MUST be bilingual English/Spanish Perform the full scope of Registered Dietitian practices; including, but not limited to, providing virtual lifestyle counseling visits to improve nutrition and dietary quality, mental health and developing coping skills, and building health behavior and lifestyle habits that align with participant’s goals and values. Work cooperatively with Clinical Project Managers, Coordinators, and site personnel to complete visits and submit accurate source documentation. Sets appointments with subjects within the required appointment window. Completes virtual visits for clinical trial subjects. Maintains all necessary licenses, certifications, credentialing materials and other required documents. Regularly stay informed on the latest nutrition and food health updates. Performs additional duties and responsibilities as deemed necessary. Required Qualifications Bachelor’s degree from an accredited dietetics program (If CDR examination was before January 1, 2024) Graduate degree from an accredited dietetics program (If CDR examination was on or after January 1, 2024) Registered Dietitian (RD) or Registered Dietitian Nutritionist (RDN) Certification by the Commission on Dietetic Registration (CDR) Current State Dietitian License/Certification in good standing (if applicable) Personal Incentives Gain CMRD GCP training certification Be a member of our general staffing pool No research experience required, on the job training provided Contribute to advancements of truly life changing treatments #LI-BJ1 Standard Rate: $46.00 Hourly plus commute, mileage, training, and administrative pay. Please contact Brandi Johnson at (303) 764-4289 or at brandi.johnson@pcmtrials.com today to learn more about our opportunities where you can make a difference in your own career! Professional Case Management is an Equal Opportunity Employer. - Rewrite
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We are seeking a Registered Dietitian (RD) for a per diem/PRN position at PCM Trials. As an RD with PCM Trials, you will provide nutritional services defined in a clinical trial setting, either virtually or in-person, to support clinical trial participants.
For more information or to apply, please contact Brandi Johnson at (303) 764-4289 or email at brandi.johnson@pcmtrials.com. Join us at PCM Trials and make a meaningful difference in your career and the lives of others!
Professional Case Management is an Equal Opportunity Employer.
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This Remote position located in the West Coast USA will be working with Provident Research Inc. in a dedicated Functional Source (embed) relationship. Our client is a major manufacturer of Medical Devices and this role is responsible for managing clinical activities at multiple study sites, as well as fostering strong, productive relationships with colleagues within the Organization. Interviews are being scheduled now to fill immediate openings. Previous Medical Device experience Mandatory. Responsible for managing clinical study activities for multiple sites in single or several Clinical Projects. Oversees performance of appointed study sites conducting company initiated clinical studies. Responsible for the site visits, monitoring, communication and deliverables for the assigned study sites. Serves as a member of the clinical study team and is the liaison between Clinical Operations and Study Site personnel for the specific clinical projects. This opening is immediate due to expansion. Benefits: This position affords you an opportunity to experience many different aspects of the clinical development industry. Our client is proud to offer a career pathway that looks to internal candidates for promotion. For the right individuals, this position offers a competitive salary along with: Medical, Dental, and Vision Disability Life Insurance 401(k) Plan Paid Vacation and Holidays Education A Bachelor Degree is required. Experience Previous Regional monitoring required Requires understanding and application of regulations and standards applied in clinical research areas Relevant industry certifications preferred (i.e. CCRA, RAC, CDE) Demonstrated competencies in the following areas are required: Leadership Strong Written and Verbal Communications Strong organizational skills Ability to travel Regionally up to 65% Attention to details Key Job Activities: Build relationships with investigators and site staff Monitor patient safety on-site (review for missing SAEs, AEs, ConMed) and address protocol violations Take responsibility for specific tasks on projects, or acts as the main CRA contact on individual projects Perform on site visits in accordance with the monitoring plan Conduct on-site study-specific training (if applicable) Perform site facilities inspection Monitor and maintain ICH-GCP compliance About Provident Research Inc: PRI is dedicated to providing our employees with the tools to succeed. Come and join the movement! - Rewrite
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Company: Provident Research Inc.
Location: Remote, West Coast USA
Provident Research Inc. is seeking a Clinical Research Associate (CRA) for an immediate opening. This remote position is dedicated to managing clinical activities across multiple study sites for a major Medical Device manufacturer. The role involves overseeing site performance, managing site visits, and ensuring strong, productive relationships with internal and external stakeholders.
Provident Research Inc. is committed to providing employees with the tools they need to succeed. Join us and be part of a dynamic team focused on advancing clinical research and making a meaningful impact.
Apply now to be part of a growing company that values your expertise and offers a supportive work environment.
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We are looking for a Sr. Clinical Research Project Manager to join our team! APPLY DIRECTLY at https://cpcclinicalresearch.org/careers/ (internal job listing Sr. Clinical Operations Manager) Are you well organized, but adaptable to unexpected changes? Someone who is able to see the bigger picture, without losing sight of the day-to-day tasks? If the answer is yes, keep reading! This role serves as the primary point of contact for industry sponsored clinical trials, Endpoint and Specialty Services activities, as well as any additional assigned projects. General Responsibilities: Work closely with the Head of Research and Community Health Operations and Head of Endpoint and Specialty Services to ensure overall quality of project services, proactive issue resolution and development of systems to standardize and improve project management practices as well as the whole ARO’s efficiency. Serve as a mentor to other Clinical Operations Managers, including providing guidance on what efforts and activities are required to ensure the overall quality of project services and deliverables. Oversee clinical operations management activities when delegated to a Clinical Trial Manager (CTM). For single-site or smaller multi-center studies in which these activities are not delegated to a CTM: o Manage site identification, evaluation, initiation, contracting/budget negotiation, and site monitoring processes as required by contract. o Identify the required regulatory documents for investigational product (IP) release and oversee documents collection. o Prepare central IRB submissions; oversee site IRB approvals and ensure collection of all new or expiring Investigator regulatory documents after site activation. o Oversee the development of project-specific essential documents for site oversight and development of site materials. o Review and finalize monitoring visit reports and follow-up letters with Clinical Research Associates (CRAs). o Work with CRAs on overall site management including identification, and resolution of site related compliance issues. o Prepare study enrollment reports and review site issues with the project team. o Manage and approve site payments as applicable. Contribute to process improvement, including but not limited to review and/or development of SOPs, and development and/or implementation of methods to improve quality of sponsor deliverables. Define and monitor project scope, timelines and deliverables from project initiation to close-out in collaboration with the Head of Research and Community Health Operations. Identify project-specific training for team members and notify appropriate designee to ensure completion and filing of training documentation. Oversee trial-related activities and provide performance feedback to supervisors for all project team members. Participate in the review, development and testing of study databases. Provide investigational product or device tracking and disposition as required by project. Develop and manage site and vendor contracts including investigational product (IP) supply, interactive voice/web response system, electronic data capture system, core labs and other applicable clinical services. Identify vendors and manage vendor services. Provide expert advice in the design, writing and/or review of all project-related essential documents including protocols, project management plans, case report forms, statistical analysis plans, project management plans, ICF templates, study procedure manuals, source documents, site newsletters, study reports, resource tools, monitoring plans and report templates. Develop and manage multidisciplinary project team members. Organize, plan for, and produce minutes for project team meetings. Proactively identify project issues, propose resolutions to the project team, applicable heads of departments, CPC executives and/or the sponsor, and then track implementation of resolution through to completion and efficacy checks. Ensure the overall quality of project services and deliverables. Provide necessary updates and reports to the sponsor as outlined by the contract. Plan and oversee the execution of investigator meetings as contracted. Work with the business development team on budgets, proposals and change orders. Assist Business Development with benchmarking for budgets and development of sponsor proposals and service agreements. Ensure both CPC and sponsor are aware of and in agreement on any change in project scope that has a financial or resource impact. Provide timely feedback to the Head of Research and Community Health Operations on the progress of project assignments. Routinely advise management regarding the overall project status. Provide Head of Trial Master File scope of services to enable him/her to establish and maintain Trial Master Files (TMFs) and project document files, both electronic and paper. Adhere to local, federal and international regulations, guidelines and CPC Policies, Standard Operating Procedures (SOPs) and Work Instructions (WIs). Use appropriate discretion to proactively identify when there is a need to deviate from policies, procedures or plans and ensure deviations are appropriately documented. Supervise and evaluate performance of all staff reporting to this position, if applicable. Additional activities as required. Endpoint and Specialty Services Responsibilities: Define and monitor Endpoint and Specialty Services scope, timelines and deliverables from project initiation to closeout with assistance from study assigned Clinical Operations Manager and the Head of Endpoint and Specialty Services. Provide timely feedback to the Head of Research and Community Health Operations, and the Head of Endpoint and Specialty Services on the progress of project assignments. Routinely advise management regarding the overall project status. Manage contracted deliverables for external committees (e.g., data safety monitoring boards, clinical endpoint committees), including but not limited to meeting scheduling, generation of meeting minutes and distribution of meeting materials. Oversee SAE process and assure execution of safety plans. Accurately track receipt, entry, upload and the processing of photos, acetate tracings, and other source documents submitted from sites. Contact appropriate individuals (e.g., study site staff or study site Clinical Research Associate) regarding incomplete, inaccurate, or missing photos, acetate tracings, and other Endpoint and Specialty Services Core Lab documents as required by the project. Oversee timely and accurate entry and cleaning of data for all study databases; maintain and file data management documentation as required. Manage acquisition and supply of Endpoint and Specialty Services-specific materials to study sites. Provide feedback to study sites on tracing and quality issues, as required by project. Manage and conduct Endpoint and Specialty Services CPC Core Lab activities as deemed necessary. Qualifications: A Nursing or BA/BS in a scientific field (or equivalent knowledge/experience). 5 years of experience in a clinical research setting (required). 3 years of sponsor or CRO clinical research project/clinical operations management experience. Demonstrated ability to successfully execute all aspects of sponsor/CRO clinical trial management, as well as the ability to mentor and oversee the activities of other COMs. Thorough knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials. Proficiency in Microsoft Office, particularly Outlook, Word and Excel. Excellent communication and organizational skills. Great attention to detail. Exemplary skills leading and managing multi-disciplinary teams in a clinical research setting. Ability to organize, instruct and supervise staff, while promoting group effort and achievement. Ability to adapt quickly to new situations, manage conflicts and resolve problems effectively. Willingness to travel 20-25%. Targeted Compensation: $95,045 - $115,000 annually Note: Viable applicants will be required to pass a background and education verification check. About CPC: About CPC: CPC is an academic research organization that offers full service clinical trial design, oversight, and management with rapid access to Key Opinion Leaders in a variety of therapeutic areas. With over 30 years of experience, CPC has provided services to over 150 clinical trials in a variety of indications, with an emphasis on cardiovascular, wound healing, diabetes and more. CPC has expertise in managing clinical trials from a variety of funding sources including Industry, NIH, and Investigator Initiated trials. CPC Community Health focuses on innovative programs that reach into communities to help people find effective ways to become active, empowered and healthy. http://www.cpccommunityhealth.org/ CPC offers: * Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.) * Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately) * 11 paid holidays * 15 - 25 vacation days based on years of service * Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours) * In-suite exercise and relaxation room * Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics) * Flexible and remote work schedules available for certain positions Visit our web site to learn more about us and values we embrace: https://cpcclinicalresearch.org/. An Equal Opportunity Employer CPC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race (including traits historically associated with race, such as hair texture and length, protective hairstyles), sex, color, ancestry, sexual orientation, gender identity, gender expression, marital status, religion, creed, national origin, disability, military status, genetic information, age 40 and over or any other status protected by applicable federal, state or local law. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors. Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act (ADA) and certain state or local laws. If you need assistance, please email our Human Resources team at careers@cpcmed.org. - Rewrite
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Company: CPC Clinical Research
Location: Remote
Apply Now: Sr. Clinical Operations Manager Position
Are you an organized and adaptable professional who can balance strategic vision with day-to-day tasks? If so, we want to hear from you!
As a Sr. Clinical Research Project Manager at CPC Clinical Research, you will serve as the primary point of contact for industry-sponsored clinical trials, Endpoint and Specialty Services activities, and other assigned projects. This role involves overseeing clinical operations, mentoring Clinical Operations Managers, and ensuring the quality and efficiency of project services.
CPC Clinical Research is a leading academic research organization with over 30 years of experience in clinical trial design and management. We specialize in cardiovascular, wound healing, diabetes, and other therapeutic areas, and focus on innovative community health programs.
Learn more about us and our values at: CPC Clinical Research
Equal Opportunity Employer: CPC provides equal employment opportunities without regard to race, color, sex, sexual orientation, gender identity, national origin, disability, military status, or any other protected status. For assistance, email our HR team at careers@cpcmed.org.
Apply now to join a dedicated team making impactful advancements in clinical research!
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Entry Level Epic Research Analyst Consultant Opportunity! Required Skills: Minimum 2 years experience as an EPIC analyst (EPIC Building/Implementation) Required Certifications: Research Clinical & Research Billing Daily Job Duties: Research study build, no incident tickets or build for upgrades Equipment will not be provided – must use their own and will remotely log into system - Rewrite
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Position: Epic Research Analyst Consultant
Location: Remote
Required Skills:
Required Certifications:
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Additional Information:
If you have the required experience and certifications and are ready to take on an entry-level role with a focus on research study build, we encourage you to apply!
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This Remote position located in the West Coast USA will be working with Provident Research Inc. in a dedicated Functional Source (embed) relationship. Our client is a major manufacturer of Medical Devices and this role is responsible for managing clinical activities at multiple study sites, as well as fostering strong, productive relationships with colleagues within the Organization. Interviews are being scheduled now to fill immediate openings. Previous Medical Device experience Mandatory. Responsible for managing clinical study activities for multiple sites in single or several Clinical Projects. Oversees performance of appointed study sites conducting company initiated clinical studies. Responsible for the site visits, monitoring, communication and deliverables for the assigned study sites. Serves as a member of the clinical study team and is the liaison between Clinical Operations and Study Site personnel for the specific clinical projects. This opening is immediate due to expansion. Benefits: This position affords you an opportunity to experience many different aspects of the clinical development industry. Our client is proud to offer a career pathway that looks to internal candidates for promotion. For the right individuals, this position offers a competitive salary along with: Medical, Dental, and Vision Disability Life Insurance 401(k) Plan Paid Vacation and Holidays Education A Bachelor Degree is required. Experience Previous Regional monitoring required Requires understanding and application of regulations and standards applied in clinical research areas Relevant industry certifications preferred (i.e. CCRA, RAC, CDE) Demonstrated competencies in the following areas are required: Leadership Strong Written and Verbal Communications Strong organizational skills Ability to travel Regionally up to 65% Attention to details Key Job Activities: Build relationships with investigators and site staff Monitor patient safety on-site (review for missing SAEs, AEs, ConMed) and address protocol violations Take responsibility for specific tasks on projects, or acts as the main CRA contact on individual projects Perform on site visits in accordance with the monitoring plan Conduct on-site study-specific training (if applicable) Perform site facilities inspection Monitor and maintain ICH-GCP compliance About Provident Research Inc: PRI is dedicated to providing our employees with the tools to succeed. Come and join the movement! - Rewrite
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Location: West Coast USA (Remote)
Company: Provident Research Inc.
About the Role: Join Provident Research Inc. in a dedicated Functional Source (embed) role, managing clinical activities for multiple study sites. This position, supporting a major Medical Device manufacturer, is responsible for overseeing site performance and fostering strong relationships within the organization. Immediate openings are available due to expansion.
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Qualifications:
Benefits:
About Provident Research Inc.: Provident Research Inc. is dedicated to empowering its employees with the tools needed to succeed. Join us and be part of an organization that values growth and development.
To Apply: If you meet the qualifications and are interested in this opportunity, apply now and contribute to advancing clinical research with us!
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Your main responsibilities as an Epidemiologist: · Perform feasibility analysis for studies · Plan observational studies and draft protocol synopsis (or protocol concept sheet) · Determine observational study design criteria – including source data, analytical methods and analysis plans · Draft and review observational study protocols · Draft and review observational study analysis specifications, including statistical analysis plans (SAPs) What we are looking for in an Epidemiologist: · Graduate degree in Epidemiology (Minimum Masters Degree, PhD candidates accepted) · (7 – 10)+ years industry experience as an epidemiologist · Oncology and safety RWE/RWD experience preferred About R&D Partners: R&D Partners is a national staffing firm focused in the areas of: Scientific, Clinical Research and Engineering. Our team offers well over 200 years of combined staffing experience providing consulting, direct hire & outsourcing solutions with our west coast offices in San Francisco, Redwood City and San Diego, CA and our east coast offices located in Harrisburg, PA and Tampa, FL. The cornerstone of our success: a knowledgeable and experienced recruiting team. Our life sciences recruiters, clinical research recruiters and engineering recruiters are uniquely specialized. After a detailed assessment of our clients’ needs, we can then identify appropriate candidates utilizing our established network of professionals. R&D Partners takes a proactive approach to recruiting, establishing relationships with experienced passive candidates so when the time is right, we can combine our candidates’ talents with our clients’ opportunities. - Rewrite
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Location: [Specify Location or Remote]
Role Overview: As an Epidemiologist with R&D Partners, you'll play a key role in designing and implementing observational studies. Your expertise will guide the feasibility analysis, protocol development, and analysis planning for impactful research studies.
Key Responsibilities:
What We’re Looking For:
About R&D Partners: R&D Partners is a national staffing firm specializing in Scientific, Clinical Research, and Engineering roles. With over 200 years of combined staffing experience, we provide consulting, direct hire, and outsourcing solutions. Our offices are located on both coasts: San Francisco, Redwood City, San Diego, Harrisburg, and Tampa.
Our success is driven by a knowledgeable recruiting team dedicated to understanding client needs and connecting them with the best talent through proactive recruiting and established professional networks.
To Apply: If you meet the qualifications and are interested in advancing your career with R&D Partners, please reach out to us to learn more about this exciting opportunity.
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The incumbent will be responsible for assisting in the daily oversight, training, and resource allocation of the Data Management Staff, working on new initiatives and related projects ensuring that all tasks and projects are completed in a timely and efficient manner, and interacting with other Coalition functional areas and industry collaborators to support the various needs of the department and company. Preference will be given to candidates who can work a hybrid schedule with 1-2 days/wk in our Center City Philadelphia office, but remote candidates with experience will be strongly considered. Responsibilities: Responsible for assisting in the management and daily oversight of data management staff. Development of data management and regulatory use related SOP and work instructions. Mentors and trains data management staff. Serves as a liaison to industry sponsors when collaborating on data management related deliverables. Serves as a liaison to Medidata Rave for Rave-related initiatives. Assists with study building and liaises with study builders to ensure communication flow when updates to forms are needed on a study specific and global level. Develops and/or reviews standard library of CRFs, edit checks, and custom functions. Serves as SME for CDASH/CDISC compliance as well as contained SDTM mapping Assists with and oversees implementation of each clinical study database into production. Oversees projects and assignment of projects as necessary. Assists the Senior Director by providing input into improving processes and implementation of new procedures. Oversees the maintenance of all Data Management department SOPs. Authors related SOPs, WI, and other documentation and tools to enhance the functioning of the Data Management department. Serves as the primary contact for the Data Management department, when the Senior Director is unavailable. Participates in all required meetings and conference calls, including industry collaborations. Reviews contracts and scopes of work for Industry collaborations. Liaises with Senior Director, Clinical Research and industry collaborators to successfully deliver negotiated data management contract deliverables. Develops and presents data management presentations. Assists with the department’s hiring process. Assess relevant training needs for staff in consultation with Senior Director, including assessment methods and productivity metrics. Also includes any relevant study build topics such as validations, migrations, etc. Works with leadership and Project Managers to assess and identify training needs across the office. Participates in the performance review of junior staff. Manages multiple priorities, assesses needs and adjusts workloads accordingly. Provides effective feedback in a sensitive and diplomatic manner. Maintains an objective and neutral perspective when evaluating the work of fellow coworkers. Assumes responsibility for multiple special projects, as assigned by the Senior Director, Clinical Research Desired Experience A minimum of five (5) years of experience in data management for clinical research trials (oncology). Data management experience in a pharmaceutical company or CRO. Experience in oncology clinical research. Thorough understanding of data collection and management practices related to oncology-specific clinical trials. Strong Medidata Rave experience. Understanding and familiarity with regulatory use related to data management (including global data management experience) preferred. Education A bachelor’s degree from an accredited institution of higher education or equivalent work and/or relevant professional experience is required. Medidata certifications for data management. About Coalition of Cancer Cooperative Groups: The Coalition of Cancer Cooperative Groups is a unique nonprofit organization with one mission, improving patient awareness of cancer clinical trials, facilitating access, and promoting participation. Through innovative programs and services, the Coalition examines and confronts key issues impeding cancer research. The Coalition of Cancer Cooperative Groups was established in 1997 to address improving the cancer clinical trials system. Today, the Coalition is comprised of members from National Cancer Institute-sponsored Cooperative Groups, the country's leading patient advocacy organizations, and thousands of oncology and cancer research specialists. The Coalition also works with its partners in the healthcare industry to streamline and promote cancer clinical trials in both the public and private sectors. - Rewrite
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Location: Center City, Philadelphia (Hybrid preferred, remote considered)
Company: Coalition of Cancer Cooperative Groups
About Us: The Coalition of Cancer Cooperative Groups is a unique nonprofit organization dedicated to improving patient awareness of cancer clinical trials, facilitating access, and promoting participation. Established in 1997, we work with National Cancer Institute-sponsored Cooperative Groups, leading patient advocacy organizations, and oncology specialists to streamline and promote cancer clinical trials.
Position Overview: The Data Management Supervisor will assist in daily oversight, training, and resource allocation for the Data Management Staff, ensuring timely and efficient completion of tasks and projects. This role involves interacting with various Coalition functional areas and industry collaborators to support departmental and company needs.
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Qualifications:
Benefits: Join a mission-driven organization dedicated to advancing cancer research through innovative programs and services. This position offers a competitive salary and benefits package, including medical, dental, and vision insurance, disability and life insurance, a 401(k) plan, paid vacation and holidays, and opportunities for professional growth.
If you are passionate about making a difference in cancer research and meet the qualifications, we encourage you to apply and join our team in our mission to improve patient awareness and participation in cancer clinical trials.
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Full job description About us We are a small business with a Big vision. We are committed to great service and true recovery. We are driven by collaborations, partnerships with team members, families and the thought of repairing all forms of brokenness in the people we service and are seeking individuals who love the work they do and are passionate to make a difference. Our work environment includes: Remote Hybrid Modern office setting Growth opportunities Wellness programs Responsibilities: - Conduct individual and group counseling sessions with clients - Assess and evaluate patients to determine appropriate treatment plans - Provide crisis management and intervention as needed - Utilize various therapeutic techniques such as dance therapy, group therapy, and applied behavior analysis - Collect and analyze data to monitor client progress and adjust treatment plans accordingly - Collaborate with other healthcare professionals to ensure comprehensive care for clients - Stay up-to-date with clinical research and best practices in counseling Experience: - Proven experience in providing counseling services, preferably in a clinical setting - Strong knowledge of therapeutic techniques and interventions - Familiarity with coding and documentation requirements for insurance purposes - Excellent communication and interpersonal skills - Ability to work effectively in a multidisciplinary team Licensed Requirement: LCSW-C, LCPC, Skills: - Group therapy - Coding - Data collection - Clinical research - Crisis management - Individual/group counseling - Patient assessment - Social work - Applied behavior analysis Note: This job description is intended to provide a general overview of the position. It is not exhaustive and may be subject to change or modification based on the needs of the organization. Job Types: Part-time, Full-time, Contract Pay: $60,000.00 - $100,000.00 per year Benefits: Flexible schedule Medical specialties: Home Health Psychiatry Schedule: 4 hour shift 8 hour shift Evening shift Monday to Friday Weekend opportunities Work setting: Remote Hybrid work Job Types: Full-time, Part-time, Contract Salary: $72,159.00 - $100,000.00 per year Expected hours: 10 – 40 per week Benefits: 401(k) Dental insurance Flexible schedule Health insurance Paid time off Professional development assistance Vision insurance Medical specialties: Home Health Psychiatry Schedule: 4 hour shift 8 hour shift Choose your own hours Day shift Monday to Friday Weekends as needed Work setting: Clinic Private practice Remote Telehealth Work Location: Remote Edit job Pending View public job page About DPC WELLNESS: This is a great flexible position allows you great work life balance to make decent salary while having freedom to balance your life. Bonus opportunities. Small team, great flexibility opportunity and bonus potential. Part time and full time position available. Hybrid position. - Rewrite
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Company: DPC Wellness
About Us: DPC Wellness is a small business with a big vision, dedicated to delivering exceptional service and fostering true recovery. We are committed to collaboration and partnerships with team members, families, and the people we serve, aiming to repair all forms of brokenness. We are seeking individuals who are passionate about their work and making a difference.
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Licensing Requirements: LCSW-C, LCPC
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Job Types: Full-time, Part-time, Contract
Salary: $72,159.00 - $100,000.00 per year
Expected Hours: 10 – 40 hours per week
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Location: Remote
DPC Wellness offers a flexible work environment that supports a healthy work-life balance while providing opportunities for a competitive salary and bonuses. Whether part-time or full-time, our small team environment fosters flexibility and growth. Join us and make a difference!
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$76,900 to $104,800 per year Estimated pay Job Title: Director- Clinical Development, Ophthalmology Reports to (Title): CEO Location: Remote Exempt/Non-Exempt: Exempt Direct Reports: No Department: Clinical Science Job Summary: Responsible for driving the US or global clinical development strategies and execution for assigned investigational and/or marketed products in the Ophthalmology Therapeutic Area (TA). The incumbent will be responsible for providing critical input into the strategy, development, management and implementation of Phase 1-4 clinical studies by closely working with the Clinical Ops team; providing medical input on the clinical development plan. Essential Job Functions: Clinical Development Expertise & Strategy The Medical Director, Ophthalmology, will provide overall clinical scientific leadership for Exegenesis Bio’s Ophthalmology programs and have responsibility for our clinical development strategy and execution of clinical trials in this area Develop the study protocol synopsis, leads the analysis of benefit/risk for clinical development protocols and the final study protocol validation and protocol amendments; Medical support to clinical operation team during the clinical feasibility Identifies and builds relationships with principal investigators (PI), key opinion leaders (KOL) in drug development. Identifies and cultivates thought leaders in order to gain their inputs on emerging science in drug and biomarker research, disease knowledge, and design of clinical development studies and programs Maintains a strong medical/scientific reputation within the assigned disease areas. Has in-depth knowledge of etiology, natural history, diagnosis, and treatment of the disorders. Holds strong expertise in the disease areas by attending scientific conferences and ongoing review of the literature Keeps abreast of development and regulatory issues related to other competitive or relevant compounds in development and how our portfolio fits into the competitive landscape Medical Monitoring Leads medical data review of trial data, including eligibility review; ensure continuous medical review of aggregated data during clinical trial conduct (DSUR, medical safety, statistical outputs of unmasked/masked data) Serve as a Clinical Trial Lead, holds responsibility for site interactions such as medical questions and education (specific disease areas, drug mechanisms of action, protocol requirements, safety management guidelines etc.) Clinical training for internal stakeholders and clinical trial sites Holds responsibility for assessment of key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees safety narratives Fulfills GCP and compliance obligations for clinical conduct and maintains all required training Health Authority Interactions & Publications Contributes to and serves as medical point of expertise in key Health Authority interactions and advisory board meetings Authors/drafts clinical content for CSRs, regulatory reports, briefing books and submission documents to support closure, clinical narratives, reporting and filling of the study Job Requirements: Experience / Education Bachelor Degree in related scientific field is required; US board-certified or-eligible (or foreign-equivalent) MD is strongly preferred; Minimum of 3 years of clinical medicine experience; Minimum of 3 years of industry experience in drug development or biomedical research experience in academia; Ophthalmology experience is required; gene therapy experience is plus not required. Knowledge / Skills / Abilities: Recognized expertise in clinical trials: working understanding of statistical principles, medical monitoring; demonstrated ability to perform literature research, analyze and author clinical trial publications; Thorough knowledge of the whole processes of clinical trials, clinical research concepts, practices, and GCP and ICH Guidelines Has working knowledge of GCP, ICH, US FDA and EMEA regulations, knowledge of relevant FDA regulations and guidelines as well as those of the EU and other health authorities; experience in interactions with the FDA is essential Proven success record in Phase I-IV clinical research studies, trial design, IND submission, and marketing approval-directed filings Proven ability to represent the Company’s interests effectively in interactions with partners and regulatory agencies. Experience communicating and interacting with investigators, KOLs, and advisors Experience working with the principles and techniques of data analysis, interpretation and clinical relevance Must have strong consensus-building skills and the ability to lead multi-disciplinary teams towards sound decision-making. Ability to develop and implement strategic growth plans. Ability to work collaboratively with cross-functional team to support the management of large volumes of data Ability to operate and thrive in a fast-paced and hands-on environment; demonstrated flexibility. Demonstrated success of taking initiative in a team setting Comfortable with ambiguity, yet be self-motivated and timeline driven Ability to travel up to 25% as needed An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. About the company: Exegenesis Bio is a clinical-stage global cell and gene therapy company that operates in Philadelphia, Boston, China, and Singapore. Founded in 2019 with strong financial backing, the company has built a broad pipeline of innovative genetic medicines and fully integrated manufacturing capabilities. The company is advancing an early to clinical-stage gene therapy pipeline with three initial focused therapeutic areas: CNS, ophthalmology, and Liver. The company’s vision is to develop and increase access to gene and cell therapies for patients around the world. Benefits •Medical, Dental and Vision Insurance and FSA •Generous Paid Time Off options, including Vacation and Sick time, plus national holidays •401(k) match and annual company contribution • Company-paid life insurance, AD&D and LTD •Employee wellness program- Gym reimbursement •Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions •Long Term Incentive Plan for eligible positions •Referral bonus program - Rewrite
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Reports to: CEO
Location: Remote
Department: Clinical Science
Job Summary: The Director of Clinical Development in Ophthalmology is responsible for leading the clinical development strategies and execution for investigational and marketed products in the Ophthalmology Therapeutic Area (TA). This role involves collaborating closely with the Clinical Operations team, providing medical input on clinical development plans, and ensuring the success of Phase 1-4 clinical studies.
Essential Job Functions:
Clinical Development Expertise & Strategy
Medical Monitoring
Health Authority Interactions & Publications
Job Requirements:
Experience / Education
Knowledge / Skills / Abilities:
Benefits:
About Exegenesis Bio: Exegenesis Bio is a clinical-stage global cell and gene therapy company with operations in Philadelphia, Boston, China, and Singapore. Founded in 2019, the company focuses on developing genetic medicines, particularly in CNS, ophthalmology, and liver diseases. Exegenesis Bio aims to increase access to gene and cell therapies worldwide
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Kolkata | Mukundapur |Alaska :
Anchorage | Barrow | Bethel | Juneau | Wrangell |Arizona :
Chandler | Kingman | Lake Havasu City | Peridot | Tempe | Tucson | Yuma |California :
Brisbane | Crescent City | Davis | El Monte | Emeryville | Foster City | Fremont | Irvine | La Jolla | Los Angeles | Martinez | Mountain View | Nevada | Oakland | Pacheco | Palo Alto | Pasadena | Pleasanton | Redwood City | Riverside | Sacramento | San Bernardino | San Diego | San Francisco | San Gabriel | San Jose | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | Stanford | Vallejo | West Valley City | Whittier | Willits |Colorado :
Denver |Connecticut :
Storrs |D.C :
Washington |Florida :
Coral Gables | Gainesville | Jacksonville | Naples | Orlando | Rueil-Malmaison | Tallahassee | Tampa | West Palm Beach |Georgia :
Atlanta |Hawaii :
Honolulu |Illinois :
Abbott Park | Champaign | Chicago | Deerfield | Lombard | Naperville |Indiana :
Bloomington | West Lafayette |Kansas :
Lawrence |LA :
Monroe | New Orleans |Maryland :
Baltimore | Elkridge | Rockville |Massachusetts :
Boston | Cambridge | Medford and Somerville | Rockland |Minnesota :
Minneapolis and St. Paul, Minnesota. |Missouri :
Fulton | St. Louis |New Jersey :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Mount Arlington | New Brunswick | Newark | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | West Orange | Westfield | Wharton | Whippany |New York :
Biddle | Buffalo | Hicksville | Ithaca | Morningside Heights | New York | Syracuse |North Caroline :
Chapel Hills | Durham | Morrisville | Philippines | Raleigh | Scottsdale |Ohio :
Columbus, |Oregon :
Bend | Corvallis | Eugene | Roseburg | Springfield |Pennsylvania :
Ambler | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | Wyomissing |Puerto Rico :
San Juan |Republic of Mexico :
Mexico |Tennessee :
Nashville |Texas :
Austin | Dallas | Houston | Richardson |Virginia :
Blacksburg | Charlottesville | Falls Church |Washington :
Goldendale | Pullman | Seattle |WI :
Madison | Wausau |Wisconsin :
Wyoming :
Cokeville |Baden-Wurttemberg :
Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Berlin :
Mitte |Brandenburg :
Berlin |Hesse :
Marburg |Hessen :
Frankfurt |Lower Saxony :
Gottingen | Hannover | Leipzig |Mecklenburg Vorpommern :
Rostock |Munich :
Bavaria |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Rhineland Palatinate :
Mainz |Rotherbaum :
Hamburg |Saarland :
Saarbrucken |Saxony Anhalt :
Halle |Schleswig Holstein :
Kiel |Denmark :
Copenhagen |Hungary :
Budapest |Istanbul :
Turkey |Serbia :
Belgrade |Switzerland :
Basel | Zurich |New South Wales :
Sydney |Queensland :
Queensland |Republic of Western Australia :
Nedlands |Hubei :
Wuhan |Republic of China :
Beijing |Tokiyo :
Osaka | Tokyo |Republic of Colombia :
Bogota |Zagreb :
Zagreb |Republic of Egypt :
Cairo |United Kingdom :
London | Salt Lake City |Republic of Ireland :
Limerick | Dublin |Republic of Korea :
Seoul |Capital of Netherland :
Amsterdam |Remote :
Switzerland | Remote | Remote - Europe | Remote, USA |Makkah :
Najran | Jeddah | Rabigh | Khulais | Riyadh |Catalonia :
Barcelona |Republic of Thailand :
Bangkok |