Bristol Myers Squibb (BMS), a global biopharmaceutical leader known for transforming patients’ lives through science, is hiring a Senior Manager, TMF Process Lead for its Hyderabad, Telangana location. This senior clinical operations role focuses on Trial Master File (TMF) governance, eTMF process optimization, compliance oversight, and cross-functional leadership across global clinical trials.
This opportunity is ideal for experienced clinical operations and eTMF professionals with strong expertise in Vault eTMF, ICH-GCP, ALCOA+, TMF inspections, and CRO oversight, looking to advance their career in a high-impact, leadership position at a top multinational pharma company.
Job Details
- Job Title: Sr. Manager, TMF Process Lead
- Company: Bristol Myers Squibb (BMS)
- Location: Hyderabad, Telangana, India
- Job Type: Full-time
- Work Model: Site-by-Design (Hybrid – minimum 50% onsite)
- Requisition ID: R1596347
- Experience Required: Minimum 5 years (TMF / eTMF focused)
Key Responsibilities – Sr. Manager TMF Process Lead
Leadership & TMF Governance
- Act as Subject Matter Expert (SME) within the TMF governance framework
- Lead TMF process groups and cross-functional initiatives
- Support inspection readiness and quality governance for active clinical studies
Training & Capability Building
- Develop TMF training materials, SOPs, templates, and job aids
- Train and coach eTMF Operations Analysts, TMF Study Leads, Archive Leads, Specialists, and CRO/FSP teams
Process Development & Documentation
- Author and maintain SOPs, Work Instructions, and Procedural Documents for TMF and archiving
- Oversee TMF compliance activities including CRO TMF transfers and Patient Data Reports
System & Technical Oversight
- Provide technical leadership for Vault eTMF, Veeva CTMS, and clinical document management systems
- Identify system gaps and implement automation and digital enhancements
- Develop and monitor TMF KPIs and compliance metrics
Audits, Inspections & Continuous Improvement
- Lead and participate in TMF audits and regulatory inspections
- Address compliance gaps using quality metrics and performance indicators
- Drive continuous improvement initiatives across TMF operations
Qualifications & Experience Required
Education
- Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Computer Science, or Business Administration
Experience & Technical Expertise
- 5+ years of experience in Clinical Development Operations with strong eTMF focus
- Deep knowledge of TMF Management, ALCOA+, ICH-GCP, GDP, and regulatory requirements
- Hands-on expertise with Vault eTMF and clinical trial documentation systems
- Experience working with CROs and global, matrixed teams
- Strong understanding of clinical trial inspection readiness and TMF audits
Key Skills
- Stakeholder management and cross-functional collaboration
- Analytical thinking and complex problem-solving
- Ability to manage multiple priorities independently
- Excellent communication and leadership skills
Why Join Bristol Myers Squibb?
- Work on life-changing clinical research in a global organization
- Strong focus on work-life balance and employee well-being
- Competitive compensation and benefits
- Inclusive, diverse, and ethical work culture
- Career growth through global exposure and leadership opportunities
Estimated Salary Range (India)
💰 ₹35,00,000 – ₹55,00,000 per annum
(Indicative range for Senior Manager TMF roles in multinational pharma companies; actual compensation may vary)
How to Apply
