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    Sr Sites Contracts & Budget Specialist

    Propharma
    5-8 years
    Not Disclosed
    United States
    10 Jan. 13, 2025
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, 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

    Senior Clinical Contract and Budget Specialist

    Company: ProPharma Group
    Location: Remote

    About ProPharma Group

    For over 20 years, ProPharma Group has been at the forefront of improving patient health and wellness by providing expert guidance that enables biotech, medical device, and pharmaceutical companies to advance scientific breakthroughs and launch new therapies. As the world’s largest Research Consulting Organization (RCO), ProPharma partners with clients through an advise-build-operate model across the entire product lifecycle. With specialized expertise in regulatory sciences, clinical research, pharmacovigilance, medical information, and R&D technology, ProPharma delivers end-to-end, customizable consulting solutions to accelerate and de-risk high-profile drug and device programs.

    Role Overview

    The Senior Clinical Contract and Budget Specialist is responsible for managing site contracts and budgets on a global scale to support clinical trial setup and execution. This role will work to ensure that all site contract documentation meets sponsor and ProPharma requirements and will collaborate with both internal and external teams to address and resolve contract-related challenges. The role will also maintain strong relationships with clients, project teams, and sites, ensuring that all relevant documents are properly submitted to the Trial Master File (TMF) as per sponsor and company SOP requirements.

    Key Responsibilities

    • Contract Administration: Manage all aspects of the contract management process, from document drafts through final completion, negotiation, and signatures.
    • Template Contract and Budget: Support the agreement on country template contracts and assist in producing site-specific contracts.
    • Negotiation Leadership: Lead negotiations on budgets and contracts with sites and internal cross-functional teams.
    • Document Execution: Oversee the execution of Clinical Trial Agreements (CTAs) and ensure proper archival and metadata capture.
    • Quality Control: Ensure contract accuracy, completeness, and compliance with required standards.
    • Project Management: Assist in managing ongoing contract issues and follow up on outstanding items according to an agreed-upon roles and responsibilities matrix.
    • Training and Process Improvement: Develop and streamline contract management processes and training materials, offering creative solutions to improve efficiency.
    • Timeline Management: Ensure compliance with country/site contracting timelines and track milestone progress using SSU tracking systems.
    • Collaboration: Work closely with internal and external teams (legal, finance, clinical operations) to resolve contract and budget issues and support the execution of contracts.
    • Trial Master File: Ensure that all relevant documents are submitted to the TMF in accordance with SOPs and sponsor requirements.
    • Confidentiality Agreements: Develop and review Confidentiality Disclosure Agreements (CDAs) per study scope, negotiating with sites and clients to execute agreements.
    • System Utilization: Use Grants Manager or equivalent systems to generate site budget templates and work with internal tools such as eTMF, CTMS, EDC, and DCT systems.
    • Workflow Development: Assist the Director of Clinical Operations in developing workflows, Work Instructions, and drafting SOPs for the Clinical Contract and Budget Specialist role.
    • Client Communication: Provide site-by-site updates on contract status or amendments during the study startup and maintenance periods.
    • Client Calls: Join client calls related to contract and budget updates as outlined in the project budget or as needed.

    Necessary Skills and Abilities

    • Contract Knowledge: Strong ability to understand, explain, and communicate contract concepts and develop detailed plans to advance contract activities.
    • Attention to Detail: Exceptional attention to detail, accuracy, and organizational skills.
    • Communication Skills: Excellent verbal, written, and presentation skills with the ability to influence and motivate teams and clients.
    • Regulatory Knowledge: Knowledge of FDA and regional regulations, ICH GCP Guidelines, and other applicable clinical trial regulations.
    • Systems Proficiency: Experience with eTMF, CTMS, EDC, and DCT systems supporting clinical trial management.
    • Problem-Solving: Strong ability to resolve contract-related issues efficiently and within timelines.
    • Collaboration: Ability to work independently and collaboratively in cross-functional teams.

    Educational Requirements

    • Required: Bachelor’s Degree or international equivalent.
    • Preferred: Advanced degree, Paralegal certification, or Law Degree.

    Experience Requirements

    • Required: Minimum of 5-8 years of experience in site and budget contracts within clinical trials.

    Why ProPharma?

    At ProPharma, we celebrate our differences and strive to create a workplace where everyone can be their authentic self. We are deeply committed to diversity, equity, and inclusion and encourage our employees to unleash their innovative, collaborative, and entrepreneurial spirits. As an Equal Opportunity Employer, we ensure that all employees are empowered to succeed in a safe and supportive environment.

    Additional Information

    • Remote Position
    • Note: ProPharma does not accept unsolicited resumes from third-party recruiters. Please refrain from contacting anyone regarding this posting.

    If you are an experienced clinical contract and budget specialist looking to make a meaningful impact on global clinical trials, we encourage you to apply!

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