Senior TMF Associate
📍 Location: Mumbai
🏢 Category: Clinical
🆔 Job ID: 255324
Job Overview
The Senior TMF Associate is responsible for managing document classification under Smart Inbox and ARC review, as well as document deletion. The role ensures Trial Master Files (eTMF) are maintained in a state of audit readiness and supports compliance with regulatory standards throughout all phases of clinical studies.
Key Responsibilities
TMF Management
Manage electronic Trial Master Files (eTMF) for trials, countries, and site artifacts in accordance with TMF processes.
Perform document classification, ARC review, and deletion (as applicable).
Conduct visual quality checks of e-documents prior to release to ensure clarity and readability.
Perform Audit Ready Checks on uploaded documents to verify accuracy and context.
Process and track essential artifacts required throughout all study phases in compliance with SOPs, GCP, and ICH guidelines.
Identify operational issues related to the TMF and implement resolutions.
Prepare TMF for QA or Sponsor audits and implement corrective actions from audit findings.
Participate in Internal and Client audits as required.
Collaboration & Client Relations
Collaborate with all members of BP&S and other study personnel.
Ensure overall client satisfaction for assigned studies.
Attend internal or external study team meetings as needed.
Training & Process Improvement
Perform training and mentoring for team members.
Participate in business improvement initiatives to enhance quality, productivity, and processes.
Other Duties
Perform additional duties as assigned by management.
Qualifications
Education
Minimum: Bachelor’s Degree in Life Sciences or Business focus.
Preferred: Master’s Degree in Life Sciences or Business.
Equivalent experience (3–6 years) in clinical research may substitute for formal education.
Experience
Minimum: 3–6 years’ experience in a clinical research environment.
Clear understanding of GCP and ICH guidelines.
Knowledge of regulatory/clinical document requirements.
Experience with Microsoft Office, web-based applications, and Adobe Acrobat Standard, including scanning software.
Skills
Excellent interpersonal skills.
Ability to maintain audit-ready documentation and ensure compliance.
Strong problem-solving and organizational skills.
Physical Demands & Work Environment
Minimal physical demands (<10%), mainly for Sponsor Kick-Off Meetings or face-to-face client meetings as requested.
Equal Opportunity
Fortrea is an Equal Opportunity Employer. Learn more about EEO & Accommodations here.
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Netherlands |Remote Australia :
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Queensland |Melbourne :
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Canada |Quebec :
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Brussels |Antwerp :
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Auckland |New Zealand :
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Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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Tallinn |Hà Nội :
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Japan | Saitama |Tokyo :
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Kyiv |Lima Region :
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Midrand | South Africa |Nišava District :
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