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    Senior Tmf Associate

    Fortrea
    2+ years
    Not Disclosed
    Mumbai
    10 Nov. 6, 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, 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 Document Management Specialist
    Company: Fortrea

    About Fortrea:
    Fortrea is a global leader in the contract research organization (CRO) industry, renowned for our scientific rigor and extensive clinical development expertise. Serving the pharmaceutical, biotechnology, and medical device sectors, we provide a comprehensive suite of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Operating in over 90 countries, Fortrea is committed to transforming drug and device development for our partners and patients worldwide.

    Job Overview:

    The Clinical Document Management Specialist will be responsible for managing the electronic Trial Master Files (eTMF) for clinical studies, ensuring they remain in an audit-ready state and compliant with regulatory and quality standards. This role involves document classification, review, and deletion processes within the eTMF system, while maintaining close collaboration with study teams and other departments.

    Summary of Responsibilities:

    As a Clinical Document Management Specialist at Fortrea, you will oversee key aspects of document management throughout the lifecycle of clinical trials, ensuring the proper handling of clinical study documents in accordance with regulatory requirements and industry standards.

    • Document Classification and Review: Manage the document classification under Smart Inbox, ARC review, and deletion processes for clinical trials. This includes ensuring all clinical study documents (trial, country, and site artifacts) are uploaded, classified, and reviewed correctly in the eTMF system.
    • Audit Readiness: Ensure that the eTMF is maintained in a state of audit readiness by performing visual quality checks on e-documents before they are released, ensuring clarity and readability, and conducting audit-ready checks on each document uploaded to ensure it is contextually accurate.
    • Regulatory Compliance: Process and track essential artifacts throughout all phases of the study in alignment with company SOPs, sponsor SOPs, Good Clinical Practice (GCP), and International Council for Harmonisation (ICH) guidelines.
    • Operational Issue Resolution: Identify and resolve any operational issues related to the TMF, ensuring the proper preparation for internal and client audits. Implement corrective actions in response to audit findings.
    • Collaboration and Communication: Work closely with internal teams and external partners to ensure client satisfaction and to support the timely and efficient completion of clinical trials.
    • Training and Mentorship: Provide training and mentorship to other team members, supporting continuous improvement and knowledge sharing.
    • Business Process Improvement: Contribute to business improvement initiatives focused on driving quality, enhancing productivity, and streamlining processes.
    • Meeting Participation: Attend internal and external study team meetings as required to support the project’s documentation needs.

    Qualifications:

    Minimum Required Qualifications:

    • Education: Bachelor’s Degree in Life Sciences, Business, or a related field.
    • Experience: A minimum of 3 to 6 years of experience in a clinical research environment, with a solid understanding of clinical document management and eTMF processes.
    • Knowledge: Strong understanding of GCP, ICH guidelines, and regulatory/clinical document requirements.
    • Technical Skills: Proficiency in Microsoft Office, web-based applications, Adobe Acrobat Standard, and the ability to apply software tools related to document management, scanning, and eTMF systems.
    • Communication: Excellent interpersonal and communication skills, with the ability to work collaboratively in a team environment.

    Preferred Qualifications:

    • Advanced Education: Master’s Degree in Life Sciences, Business, or a related field.
    • Experience: Additional experience in clinical electronic systems and eTMF platforms.
    • Knowledge: Familiarity with clinical trial processes, regulatory documents, and audit preparation.

    Physical Demands / Work Environment:

    • Travel: Minimal travel required (less than 10%) for Sponsor Kick-Off Meetings, Client Meetings, or as requested.

    Why Join Fortrea?

    At Fortrea, we are driven by a passion for overcoming barriers in clinical trials and revolutionizing the development process to bring life-changing therapies to patients faster. As a member of our team, you’ll be part of a dynamic, innovative work environment where personal growth and professional development are prioritized.

    If you are a motivated problem-solver with a passion for clinical research, we encourage you to apply and help us make a global impact on patient health.

    Fortrea is an Equal Opportunity Employer:
    Fortrea is committed to diversity and inclusion and strives to create a work environment free from harassment and discrimination. We welcome applicants from all backgrounds and are dedicated to hiring individuals based on their qualifications, skills, and experience.

    For more information about how we collect and store your personal data, please see our Privacy Statement.

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