
Takeda, a global biopharmaceutical leader with a 240-year legacy in medical innovation, is seeking a high-caliber Senior Clinical Research Associate (Sr. CRA) for its Global Portfolio Division. Based in Mumbai, this role is pivotal in managing Takeda’s rich R&D pipeline and ensuring that breakthrough therapies reach patients through rigorous clinical excellence.
The Senior CRA will be responsible for the end-to-end oversight of clinical study sites, ensuring absolute compliance with global and local regulatory standards.
Key Responsibilities & Objectives
The primary goal of this position is to manage site performance and data integrity across various phases of clinical drug development.
- Site Management: Lead the full lifecycle of site visits, including Selection, Initiation, Routine Monitoring, and Close-out.
- CRO Oversight: Collaborate with Clinical Research Organizations (CROs) to drive subject recruitment plans and enhance enrollment predictability.
- Quality & Integrity: Evaluate site practices for adherence to protocols and Good Clinical Practice (GCP). Manage Corrective and Preventive Actions (CAPAs) and audit observations.
- Progress Tracking: Monitor regulatory submissions, CRF completion, and data query resolutions to keep studies on schedule.
- Documentation: Ensure all essential site documents are filed correctly in the Trial Master File (TMF) according to local regulations.
Candidate Profile
Takeda is looking for experienced clinical research professionals with a proven track record of stable performance.
| Criteria | Requirement |
| Education | Master’s or Ph.D. in a Scientific Discipline or Healthcare. |
| Experience | Minimum 5+ years as a Clinical Research Associate (CRA) in the industry. |
| Skills | Expertise in GCP, local clinical trial regulations, and TMF management. |
| Travel | Domestic travel (20-30%) and limited international travel (10-20%). |
| Competencies | Strong negotiation, strategic thinking, and organizational problem-solving skills. |
Additional Information
- Job Location: Mumbai, Maharashtra.
- Business Unit: Global Portfolio Division.
- Employment Type: Full-time.
- Application Deadline: 15 February 2026.
How to Apply
Eligible candidates are encouraged to apply via the Takeda Careers Portal. Ensure your CV highlights your experience with site monitoring, CRO oversight, and your specific history of managing Trial Master Files (TMF).
