Senior TMF Associate
📍 Location: Mumbai
Category: Clinical
Job ID: 255324
Job Overview
The Senior TMF Associate is responsible for managing and maintaining electronic Trial Master Files (eTMF) to ensure compliance, audit readiness, and operational excellence. This role involves document classification under Smart Inbox, ARC review, document deletion, and close collaboration with study teams and stakeholders across clinical operations.
Key Responsibilities
TMF Management & Compliance
Manage eTMF (Trial, Country, and Site artifacts) for clinical studies in accordance with TMF processes and GCP/ICH guidelines.
Maintain the TMF in a state of audit readiness, ensuring quality, accuracy, and regulatory compliance.
Conduct visual quality checks of e-documents before release to confirm image clarity and readability.
Perform Audit Ready Checks (ARC) on documents uploaded in the eTMF system to ensure contextual accuracy.
Maintain and track essential artifacts throughout all phases of clinical studies as per SOPs and regulatory standards.
Smart Inbox & Document Handling
Responsible for document classification under Smart Inbox (when applicable).
Manage ARC review and document deletion processes in accordance with study-specific requirements.
Audit Support
Prepare and support QA or Sponsor audits, ensuring timely identification and resolution of findings.
Implement corrective and preventive actions (CAPA) as required based on audit outcomes.
Participate in internal and client audits as per study requirements.
Process Improvement & Collaboration
Identify and resolve operational issues related to TMF processes.
Participate in business improvement initiatives to enhance quality, productivity, and operational efficiency.
Collaborate with all members of Business Process & Support (BP&S) and ensure client satisfaction across studies.
Training & Mentoring
Provide training and mentoring to team members as needed.
Participate in internal/external study team meetings and contribute to knowledge sharing.
Qualifications
Minimum Required
Bachelor’s Degree in Life Sciences or Business (or related field).
3–6 years of experience in a clinical research environment.
Strong understanding of Good Clinical Practice (GCP) and ICH guidelines.
Knowledge of Regulatory/Clinical document requirements.
Proficiency in Microsoft Office, web-based applications, and Adobe Acrobat Standard.
Excellent interpersonal, communication, and organizational skills.
Preferred
Master’s Degree in Life Sciences or Business.
Equivalent experience (3–6 years) within a clinical research environment may substitute educational requirements.
Hands-on experience with clinical electronic systems (eTMF, Veeva Vault, etc.).
Performance & Metrics
Comply with established metrics for performance and quality.
Ensure timely and accurate document management aligned with SLA/KPI standards.
Physical Demands / Work Environment
Minimal travel required (<10%) for Sponsor Kick-Off Meetings, Client Meetings, or as requested.
Office or hybrid work environment depending on project needs.
Additional Information
Learn more about EEO & Accommodation Requests here.
Employer: Fortrea — advancing clinical research operations through compliant, efficient, and audit-ready document management systems.
Gujarat :
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Auckland |New Zealand :
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Japan | Saitama |Tokyo :
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