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    Senior Tmf Associate

    Fortrea
    2+ years
    Not Disclosed
    Mumbai
    10 Nov. 8, 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

    Trial Master File (TMF) Document Specialist - Fortrea

    Location: [Location]
    Company: Fortrea

    About Fortrea
    Fortrea is a global leader in clinical research, dedicated to scientific rigor and decades of experience in clinical development. We offer pharmaceutical, biotechnology, and medical device customers a comprehensive range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With operations in over 90 countries and a team of 19,000+ professionals, Fortrea is at the forefront of transforming the drug and device development process, improving outcomes for both partners and patients worldwide.

    Job Overview

    Fortrea is looking for a Trial Master File (TMF) Document Specialist to join our team. In this role, you will be responsible for the management of eTMF (electronic Trial Master Files) and associated document classification tasks. This position will ensure all documents are processed, tracked, and maintained in compliance with regulatory requirements and company SOPs, contributing to the overall success of clinical trials.

    Summary of Responsibilities

    • Document Classification: Manage eTMF document classification under Smart Inbox and ARC review, and perform document deletion when applicable.
    • Audit Readiness: Ensure the TMF is always in a state of audit readiness by performing visual quality checks of e-documents before release, ensuring clarity, readability, and compliance with GCP, ICH, and sponsor-specific guidelines.
    • Operational Issue Management: Identify operational issues related to the TMF and work towards effective resolutions.
    • Study Artifact Management: Process and track essential study artifacts across all study phases, ensuring compliance with SOPs, regulations, and study-specific requirements.
    • Audit Preparation: Prepare the TMF for internal quality assurance (QA) or sponsor audits, ensuring corrective actions are identified and implemented as required.
    • Collaboration: Work closely with internal teams, including Study Team Members and the BP&S team, to ensure all documents are managed and maintained according to study needs and client expectations.
    • Client Satisfaction: Ensure overall client satisfaction for all assigned studies and collaborate with other departments to drive quality and continuous process improvement.
    • Training & Mentoring: Provide training and mentorship to team members as required to ensure the accurate processing and management of TMF documents.
    • Business Improvement: Actively participate in business improvement initiatives aimed at driving quality, productivity, and process efficiency.

    Qualifications (Minimum Required)

    • Education: Bachelor’s Degree in Life Sciences, Business, or related field.
    • Experience: Minimum 3-6 years working in a clinical research environment.
    • Knowledge:
      • Clear understanding of GCP, ICH guidelines, and regulatory/clinical document requirements.
      • Proficiency in Microsoft Office products, web-based applications, and Adobe Acrobat Standard.
      • Familiarity with scanning and document management systems.
    • Interpersonal Skills: Excellent communication and collaboration skills, with the ability to work across cross-functional teams.

    Preferred Qualifications

    • Advanced Education: Master’s Degree in Life Sciences, Business, or related field.
    • Clinical Systems Experience: Previous experience with clinical electronic systems for document management and TMF processes.
    • Relevant Experience: Equivalent experience in clinical research (3-6 years) may be considered in place of specific educational requirements.

    Physical Demands / Work Environment

    • Travel: Minimal travel (less than 10%) may be required for Sponsor Kick-Off Meetings or Face-to-Face Client Meetings as needed.
    • Work Environment: This position may be performed in an office-based or remote environment, depending on the candidate’s location and the needs of the study.

    Why Join Fortrea?

    Fortrea is committed to transforming the clinical development process and delivering life-changing therapies to patients. We encourage motivated and innovative problem-solvers to join our diverse and collaborative team. At Fortrea, you'll have the opportunity to grow both personally and professionally while contributing to groundbreaking clinical trials that make a real difference in patients' lives.

    To learn more about Fortrea and explore career opportunities, visit www.fortrea.com.

    Equal Opportunity Employer

    Fortrea is proud to be an Equal Opportunity Employer. We strive to maintain an inclusive and diverse workforce and do not tolerate any form of discrimination. We make hiring decisions based on individual qualifications and the needs of our business, and we encourage all qualified individuals to apply, regardless of race, religion, color, gender identity, sexual orientation, or other protected characteristics.

    Privacy Statement

    For more information on how Fortrea collects and stores your personal data, please see our Privacy Statement.

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