Global biopharmaceutical company Bristol Myers Squibb (BMS) is hiring professionals for Trial Master File (TMF) roles in Hyderabad, India. The company is recruiting for three clinical operations positions including TMF Study Lead, TMF Study Lead โ Archival, and Senior Manager โ TMF Process Lead.
These roles are ideal for professionals with experience in clinical trial documentation, eTMF management, Good Clinical Practice (GCP), and regulatory compliance. Candidates with experience in Veeva Vault eTMF, clinical operations, and TMF inspection readiness will have strong advantages.
Working at Bristol Myers Squibb offers exposure to global clinical trials, regulatory inspections, and cross-functional collaboration with CRO partners, making it an excellent opportunity for professionals looking to advance in clinical research operations and clinical document management careers.
Job Overview
Company: Bristol Myers Squibb
Department: Clinical Operations / TMF Management
Location: Hyderabad, Telangana, India
Employment Type: Full-Time
Roles Available:
- Senior Manager โ TMF Process Lead
- TMF Study Lead โ Archival
- TMF Study Lead
These positions focus on Trial Master File governance, clinical trial documentation oversight, regulatory compliance, and eTMF system management across global clinical studies.
Key Responsibilities
TMF Governance & Compliance
- Ensure adherence to ICH-GCP guidelines, regulatory requirements, and BMS policies related to Trial Master File management.
- Maintain inspection-ready TMF documentation throughout the clinical study lifecycle.
- Monitor TMF completeness, quality, and accuracy across study, site, and country levels.
Clinical Documentation Management
- Ensure essential documents are uploaded and reconciled in the eTMF system.
- Support study start-up, maintenance, closeout, and archival processes.
- Manage document transfers from CRO partners and ensure proper archival procedures.
eTMF System Oversight
- Work with Veeva Vault eTMF and other clinical document management systems.
- Identify system gaps and implement technical improvements and automation.
- Ensure controlled access and security compliance for archived TMF records.
Quality Metrics & Inspection Readiness
- Perform risk-based quality reviews of TMF content using metrics and reports.
- Generate and monitor TMF performance KPIs.
- Support regulatory inspections, audits, and inspection readiness activities.
Cross-Functional Collaboration
- Collaborate with clinical operations teams, CRO partners, and functional stakeholders.
- Provide TMF process training and coaching to study teams and document owners.
- Participate in process improvement initiatives for TMF operations.
Required Qualifications
Education
- Bachelorโs degree in Life Sciences, Pharmacy, Clinical Research, Computer Science, or Business Administration
Experience
- 3โ5 years of TMF experience for TMF Study Lead roles
- 5+ years clinical operations experience for Senior Manager โ TMF Process Lead
- Experience working with clinical trial documentation and eTMF systems
Technical Knowledge
Candidates should have strong knowledge of:
- ICH GCP E6 guidelines
- ALCOA+ data integrity principles
- Good Documentation Practices (GDP)
- TMF Reference Model
- Clinical trial documentation lifecycle
- Veeva Vault eTMF system
Skills
- Strong analytical and problem-solving ability
- Excellent cross-functional collaboration skills
- Ability to manage multiple priorities in a fast-paced environment
- Strong communication and stakeholder management
Benefits of Working at Bristol Myers Squibb
BMS is known for offering industry-leading benefits and career growth opportunities, including:
- Exposure to global clinical development programs
- Competitive compensation packages
- Flexible work models and hybrid work options
- Learning and development programs
- Inclusive and collaborative workplace culture
- Opportunities to work with leading clinical trial technologies and systems
How to Apply
Application Link For Senior Manager โ TMF Process Lead
Application Link For TMF Study Lead โ Archival
Application Link For TMF Study Lead
