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    Trial Master File [Tmf] Administrator

    Medpace
    0-2 years
    Not Disclosed
    Cincinnati
    10 Nov. 22, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

    Job Title: Clinical Records Administrator – Trial Master File (TMF)
    Company: Medpace
    Location: Cincinnati, OH

    Job Summary
    Medpace is seeking dedicated individuals to join our team as Clinical Records Administrators, focusing on Trial Master File (TMF) management. The TMF is a critical component of clinical trials, ensuring regulatory compliance and the integrity of trial data, which supports drug or device approval. This role provides a unique opportunity to work within a collaborative team environment while building expertise in clinical research administration. Candidates with document administration experience or transferable skills are encouraged to apply, with a cover letter recommended for those with indirect experience.

    Key Responsibilities

    • Maintain and manage the electronic filing system for trial documentation.
    • Perform quality checks to ensure documents meet established standards.
    • Track and maintain electronic records to support TMF oversight.
    • Collaborate with global internal teams to ensure TMF compliance.
    • Prepare trial documents for shipment.

    Qualifications

    • Education: High school diploma or equivalent required.
    • Experience: Document administration or related experience preferred.
    • Strong attention to detail and organizational skills.
    • Excellent written and verbal communication abilities.
    • Proficiency in Microsoft Office (Excel and Outlook).

    Why Join Medpace?

    • Flexible Work Environment: Balance your professional and personal life.
    • Comprehensive Benefits: Competitive compensation and PTO packages.
    • Growth Opportunities: Structured career development pathways.
    • Employee Well-Being: Health and wellness initiatives, on-site fitness center, and local discounts.
    • Community Engagement: Support for local nonprofit organizations.

    Cincinnati Campus Highlights

    • Modern, eco-friendly campus with state-of-the-art amenities.
    • Discounts on local attractions, sports events, and gym memberships.
    • Tuition discounts for University of Cincinnati online programs.

    Medpace Overview
    Medpace is a full-service clinical contract research organization (CRO) specializing in Phase I-IV clinical development for the biotechnology, pharmaceutical, and medical device industries. We are headquartered in Cincinnati, Ohio, and employ over 5,000 professionals across more than 40 countries.

    Our mission is to accelerate the development of safe and effective medical therapeutics, leveraging regulatory expertise across oncology, cardiology, metabolic disease, endocrinology, CNS disorders, and more.

    Awards & Recognition

    • Named a Top Workplace in 2024 by The Cincinnati Enquirer.
    • Featured by Forbes as one of America's Most Successful Midsize Companies (2021-2024).
    • Honored with CRO Leadership Awards for quality, capabilities, and reliability by Life Science Leader.

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