Fortrea BSc Life Sciences Associate Job – Apply Now!
Looking for your next career move in clinical research? Fortrea is hiring TMF Associates in Bangalore for candidates with a B.Sc. in Lifesciences or a related field. If you’re detail-oriented, understand GCP-ICH guidelines, and have experience managing eTMF documents, this is your chance to join a global leader in clinical development.
Job Overview:
Manages the document classification under Smart Inbox and ARC review (as applicable) as well as document deletion.
Locations: Bangalore
Time type: Full-time
Posted on: Yesterday
End Date: May 12, 2025 (9 days left to apply)
Job requisition ID: 252238
Summary of Responsibilities:
- Maintains an understanding of applicable regulatory requirements.
- Managing electronic Trial Master Files (eTMF), (Trial, Country and Site artifacts) for clinical studies in accordance with TMF processes, working with key study personnel such as the Study Team Member – Responsible for document classification under Smart Inbox (when applicable), ARC review, document deletion. TMF Classifiers or Start Up team members as part of the SSU Vault Model typically fulfil this role (TMF Classifier).
Key Responsibilities:
- Ensure TMF is audit-ready by performing visual checks for document clarity and accuracy.
- Conduct Audit Ready Checks on eTMF documents for compliance and context.
- Meet performance metrics and track essential documents across all study phases per SOPs and GCP/ICH guidelines.
- Identify and resolve TMF-related operational issues.
- Prepare TMF for QA/Sponsor audits and implement corrective actions.
- Participate in internal and client audits as required.
- Collaborate with cross-functional teams to ensure client satisfaction.
- Support continuous improvement and process optimization initiatives.
- Stay updated on relevant regulatory requirements.
- Attend study meetings and perform additional tasks as assigned.
Qualifications (Minimum Required):
Bachelor’s Degree with a Life Sciences/Business focus.
Experience (Minimum Required):
- Minimum 6 months to 12 months’ experience working in a clinical research environment.
Clear understanding of GCP and ICH guidelines. - Knowledge of Regulatory/Clinical document requirements.
- Knowledge of Microsoft Office products, web based applications, and Adobe Acrobat Standard, plus the ability to apply related knowledge regarding scanning and other software programs.
- Excellent interpersonal skills.
Preferred Qualifications Include:
- Masters’s Degree with a Life Sciences/Business focus.
- Equivalent experience within clinical research environment of a minimum of 6 months to 12 months, may be substituted for education requirements.
- Experience working in clinical electronic systems.
Physical Demands/Work Environment:
Minimal travel (less than 10%) as required for Sponsor Kick-Off Meetings, Face to Face Client Meetings, when requested.
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