Sr. Manager, TMF Process Lead
Bristol Myers Squibb (company site, opens in a new tab)5+ yrsHyderabadOn-siteDirect career pageEst. 18–28 LPA
Posted 10h ago
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Job description
Structured overview of role & requirements
About This Role
- Lead and provide subject matter expertise within TMF governance to optimize processes and ensure quality oversight for clinical studies.
- Develop and deliver training and support to internal teams and external partners for consistent TMF process adherence.
- Implement process improvements and technical enhancements including innovation and automation to maintain TMF inspection readiness and regulatory compliance.
Minimum Requirements
- Bachelor's degree in life sciences, computer science, business administration, or related field.
- Minimum 5 years of experience in clinical development operations focusing on electronic Trial Master File (eTMF).
- Strong technical knowledge of Vault eTMF system and clinical document management systems.
- Comprehensive knowledge of ALCOA+ standards, Good Clinical Practice, ICH guidelines, and applicable local regulatory requirements.
Ideal Candidate Profile
- Experienced leader with a proven track record in TMF governance and cross-functional collaboration in clinical trial environments.
- Demonstrated expertise in process optimization, compliance management, and technical oversight of eTMF systems, especially Vault Clinical/Veeva.
- Proficient in developing and delivering training across diverse, matrixed organizations and driving continuous improvement initiatives.