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    Clinical Data Associate/Senior Clinical Data Associate

    Precision For Medicine
    4+ years
    Not Disclosed
    Remote, USA
    10 Aug. 2, 2024
    Job Description
    Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Description

    Position: Clinical Data Associate/Senior Clinical Data Associate
    Location: Precision for Medicine

    Overview:

    Precision for Medicine is seeking an experienced Clinical Data Associate/Senior Clinical Data Associate to provide comprehensive data management support throughout all phases of the clinical trial data management process. Under direct supervision, you will ensure adherence to Standard Operating Procedures (SOPs), regulatory guidelines, and study-specific plans. This role encompasses a range of responsibilities, including data cleaning and reconciliations, database testing, quality control, and collaboration within a dynamic team environment.

    Position Summary:

    The Clinical Data Associate/Senior Clinical Data Associate provides data management support and assistance in all aspects of the clinical trial data management process from study start-up to post-database lock for assigned projects under direct supervision. Standard Operating Procedures (SOPs), regulatory directives, and study-specific plans and guidelines will be followed. This position may perform database development and testing, as well as additional data management activities.

    Essential Functions:

    • Support the Lead Data Manager as a backup and/or team member, ensuring continuity, responsiveness, and timely task performance.
    • Perform data entry for paper-CRF studies as needed.
    • Conduct quality control of data entry.
    • Provide input into timelines and ensure clinical data management deadlines are met with quality.
    • Assist in developing CRF specifications from the clinical study protocol and coordinate review/feedback from all stakeholders.
    • Assist in building clinical databases.
    • Conduct database build User Acceptance Testing (UAT) and maintain quality-controlled database build documentation.
    • Assist in specifying requirements for all edit check types (electronic, manual data review, edit checks, etc.).
    • Create, revise, appropriately version, and maintain data management documentation.
    • Train clinical research personnel on study-specific CRF, EDC, and other project-related items as needed.
    • Review and query clinical trial data according to the Data Management Plan.
    • Perform line listing data review based on guidance from the sponsor and/or Lead Data Manager.
    • Run patient and study-level status and metric reporting.
    • Perform medical coding of medical terms to ensure medical logic and consistency.
    • Assist with coordinating SAE/AE reconciliation.
    • Liaise with third-party vendors such as external data and EDC vendors in a project manager capacity to support timelines and data-related deliverables.
    • Assist with SAS programming and quality control of SAS programs used in the Data Management department.
    • Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders.
    • Assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP), and Clinical Study Reports (CSRs) if required by the project.
    • Participate in the development and maintenance of SOPs and corresponding process documentation related to data management and database management activities.
    • Ensure all data management project team members have been sufficiently trained.
    • Communicate with study sponsors, vendors, and project teams as needed regarding data, database, or other relevant project issues.
    • Present software demonstrations/trainings, department/company training sessions, and project meetings.
    • Perform other duties as assigned.

    Qualifications:

    Minimum Required:

    • 4+ years of experience within Data Management
    • Bachelor's degree in a scientific or science-related field and a combination of related experience
    • Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
    • Ability to handle a variety of data management tasks and oversight
    • Excellent organizational and communication skills
    • Professional use of the English language, both written and oral
    • Basic knowledge of drug, device, and/or biologic development and effective data management practices

    Preferred:

    • Experience in a clinical, scientific, or healthcare discipline
    • Proficiency in medical coding dictionaries (MedDRA and WHODrug)
    • Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.)
    • Experience in oncology and/or orphan drug therapeutic areas

    Skills and Competencies:

    • Strong knowledge of ICH-GCP, relevant Precision Oncology SOPs, and regulatory guidance with the ability to implement and drive outcomes
    • Ability to motivate project team members to meet timelines and project goals
    • Focus on continuous improvement, making proactive assessments to enhance process efficiency and effectiveness
    • Ability to resolve project-related problems and prioritize workload to meet deadlines with minimal support
    • High degree of self-motivation, working independently and in a team environment
    • Professionalism evidenced by punctuality, commitment, service culture, positive interactions with customers and teammates, and good interpersonal skills

    About Precision for Medicine:

    Precision for Medicine is a precision medicine CRO. Our uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and a passion for rare diseases and oncology. We also work across other therapeutic areas.

    Important Notice:

    Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other characteristics protected by law. © 2020 Precision Medicine Group, LLC

    If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in your ability to access or use this online application process and need an alternative method for applying, please contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.

    It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. Please note that these offers are not associated with our company and may be fraudulent. Our organization will not extend a job offer without prior communication with our recruiting team, hiring managers, and a formal interview process.

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