Takeda is recruiting for the position of TMF Associate β TMF Center of Excellence in Bengaluru, India. The role focuses on Trial Master File (TMF) documentation, electronic Trial Master File (eTMF) processing, quality control, regulatory compliance, and clinical trial inspection readiness.
Candidates with experience in clinical research, TMF management, or document management can explore this full-time opportunity.
Job Details
| Particulars | Details |
|---|---|
| Company | Takeda |
| Job Title | TMF Associate β TMF Center of Excellence |
| Job Location | Bengaluru, Karnataka, India |
| Job Type | Full-time |
| Worker Type | Employee |
| Employment Category | Regular |
| Experience | 1+ year |
| Qualification | BSc/BA in a scientific or allied health/medical field, or equivalent experience |
| Job Requisition ID | R0192110 |
| Application Deadline | 5 November 2026 |
Position Overview
The TMF Associate will support record generation, document processing, and second-line quality control for clinical trial delivery and pharmacovigilance documentation. The role involves maintaining complete, accurate, compliant, and inspection-ready records while improving operational efficiency through standardized workflows and automation.
Key Responsibilities
- Process, classify, index, and maintain electronic Trial Master File (eTMF) study documents according to applicable SOPs, regulations, and study requirements.
- Perform second-line quality reviews to verify record completeness, accuracy, consistency, and compliance.
- Identify metadata discrepancies, record quality risks, and workflow inefficiencies and support their resolution.
- Maintain operational reports and tracking mechanisms for performance monitoring and oversight.
- Support end-to-end record workflows, including intake, review, approval, filing, retention, and archival.
- Promote workflow standardization, automation, templated solutions, and system-enabled processing.
- Collaborate with cross-functional stakeholders to resolve issues, manage escalations, and align operational priorities.
- Contribute to process documentation, training materials, knowledge resources, and inspection readiness activities.
- Support operational reports and dashboards for continuous improvement.
Eligibility and Qualifications
Candidates should meet the following requirements:
- A BSc/BA degree in a scientific or allied health/medical field, or equivalent experience.
- At least one year of experience in clinical research, TMF, and/or document management.
- Understanding of TMF management, compliance, inspection readiness, clinical trials, and the drug development lifecycle.
- Familiarity with applicable regulations and guidance, including ICH E6 (R2/R3), 21 CFR Part 11, EU CTR, and EU GVP, as applicable.
- Knowledge of ALCOA+ principles, data integrity, and Good Documentation Practices.
Preferred experience: Familiarity with Veeva Vault eTMF.
Required Skills
- Electronic Trial Master File (eTMF) document processing and management
- TMF quality control and inspection readiness
- DIA TMF Reference Model
- TMF plans and Expected Document Lists (EDLs)
- Risk-based TMF quality control and health checks
- Regulatory compliance and data integrity
- Microsoft Office applications
- Automation, analytics, and digital workflow tools
- Strong organizational, time management, and prioritization skills
- Attention to detail, problem-solving, and process improvement
- Written, verbal, and interpersonal communication
- Ability to manage multiple tasks, meet deadlines, and collaborate across teams
