Takeda is hiring for three positions in its Clinical Trial Delivery and Pharmacovigilance (PV) Documentation Excellence and TMF Center of Excellence operations in Bengaluru, Karnataka. The openings are for TMF Associate, TMF Lead, and Associate Director.
The roles focus on Trial Master File (TMF) management, electronic Trial Master File (eTMF) documentation, quality review, regulatory compliance, inspection readiness, process improvement, and clinical trial and pharmacovigilance records management.
Candidates with scientific or allied health/medical qualifications and relevant experience in clinical research, TMF, eTMF, document management, or regulated pharmaceutical environments can review the eligibility requirements below.
Takeda Recruitment 2026: Job Details
| Particulars | Details |
|---|---|
| Company | Takeda |
| Job Location | Bengaluru, Karnataka, India |
| Job Type | Full-time |
| Employment Type | Regular employee |
| Total Open Positions | 3 roles |
| Application Deadline | 28 October 2026 |
| Application Mode | Online |
| Work Area | Clinical Trial Delivery and Pharmacovigilance Documentation Excellence |
Positions Available at Takeda
1. TMF Associate, TMF Center of Excellence
- Requisition ID: R0192117
- Experience: Typically 3+ years in clinical research, TMF, records management, document management, or a related regulated environment.
- Qualification: Scientific or allied health/medical degree (BSc/BA) or equivalent experience.
- Preferred System Experience: Veeva Vault eTMF or a comparable regulated content management system.
Key responsibilities:
- Process, classify, index, maintain, reconcile, and quality-check eTMF documents.
- Perform second-line quality reviews and resolve document and metadata discrepancies.
- Maintain inspection readiness and support audits and document retrieval.
- Coordinate with study teams and cross-functional stakeholders.
- Maintain operational trackers, reports, and dashboards.
- Support workflow standardization, automation, training materials, and process improvements.
2. TMF Lead, TMF Center of Excellence – Clinical Trial Delivery and Pharmacovigilance Documentation Excellence
- Requisition ID: R0192103
- Experience: Typically 5+ years in clinical research, TMF, records management, document management, or a related regulated environment.
- Qualification: Scientific or allied health/medical degree (BSc/BA) or equivalent experience.
- Preferred System Experience: Hands-on experience with eTMF, with Veeva preferred.
Key responsibilities:
- Lead day-to-day TMF and PV records management operations.
- Provide people leadership, coaching, workload management, and performance oversight to TMF Associates.
- Monitor quality, productivity, service delivery, and compliance metrics.
- Conduct quality reviews and TMF health checks for complex and business-critical studies.
- Coordinate inspection readiness, audits, documentation retrieval, and remediation.
- Drive standardization, workflow optimization, automation, and operational improvements.
- Support training, onboarding, and capability development.
3. Associate Director, Clinical Trial Delivery and Pharmacovigilance Documentation Excellence
- Requisition ID: R0192092
- Experience: 8+ years of progressive experience in pharmaceutical, biotechnology, or CRO environments, including expertise in TMF/eTMF and/or PV documentation. The role also requires 3+ years of collaboration with global teams, vendors, and cross-functional stakeholders.
- Qualification: Scientific or allied health/medical degree (BSc/BA) or equivalent experience.
- Preferred System Experience: Familiarity with eTMF platforms, particularly Veeva, reporting tools, and dashboards. PV systems exposure is preferred.
Key responsibilities:
- Build, lead, and scale Takeda’s Clinical Trial Delivery and PV Documentation Excellence Global Capability Center.
- Lead TMF operations, document quality review, records stewardship, and inspection readiness activities.
- Oversee staffing, workforce planning, onboarding, training, competency development, and succession planning.
- Monitor service delivery, quality, productivity, compliance, and inspection readiness metrics.
- Lead quality management, risk assessments, root cause investigations, corrective and preventive actions (CAPA), and continuous improvement initiatives.
- Drive process standardization, workflow automation, AI-enabled document processing, metadata management, and analytics.
- Partner with global leadership on records governance, regulatory inspections, and enterprise records strategies.
Eligibility and Qualifications
The required qualifications and experience vary by position.
- TMF Associate: Scientific or allied health/medical degree or equivalent experience, with typically 3+ years of relevant experience.
- TMF Lead: Scientific or allied health/medical degree or equivalent experience, with typically 5+ years of relevant experience.
- Associate Director: Scientific or allied health/medical degree or equivalent experience, with 8+ years of progressive experience in pharma, biotech, or CRO environments and 3+ years collaborating with global teams, vendors, and cross-functional stakeholders.
Relevant experience may include clinical research, TMF/eTMF operations, pharmacovigilance documentation, records management, document quality review, and inspection readiness.
Required Skills and Technical Knowledge
Candidates should review the skills relevant to their preferred position.
- eTMF document processing, metadata management, reconciliation, and quality review.
- Knowledge of ICH E6 (R2/R3), 21 CFR Part 11, EU Clinical Trials Regulation (EU CTR), and EU Good Pharmacovigilance Practices (EU GVP), as applicable.
- ALCOA+ principles, data integrity, and Good Documentation Practices.
- DIA TMF Reference Model, TMF plans, Expected Document Lists (EDLs), and risk-based TMF quality control.
- Inspection readiness, audit support, and document retrieval.
- Strong analytical, organizational, communication, and problem-solving skills.
- Microsoft Office proficiency and familiarity with automation, analytics, and digital workflow tools.
- Process improvement, stakeholder coordination, and the ability to manage competing priorities.
For the TMF Lead and Associate Director positions, leadership, coaching, performance management, and operational improvement capabilities are also relevant.
