Bristol Myers Squibb (BMS) is a global biopharmaceutical company committed to transforming patients’ lives through science. With a vision as inspiring as “Transforming patients’ lives through science™”, BMS empowers its employees to make a meaningful impact in the world. The company fosters an inclusive culture that values diversity, innovation, and collaboration, ensuring that every team member can thrive and contribute to life-changing careers.
BMS offers a dynamic work environment where employees are encouraged to grow and excel. From optimizing production lines to pioneering breakthroughs in cell therapy, the work at BMS is anything but ordinary. The company also prioritizes work-life balance, offering competitive benefits, flexible work arrangements, and programs that support both professional and personal growth.
Job Description: ETMF Operations Analyst
Division: Global Development Operations / Global Clinical Compliance and Continuous Improvement / Global Clinical Documents, Submissions, and Disclosure
Functional Area Description:
The eTMF (electronic Trial Master File) Operations team ensures the completeness and accuracy of the Trial Master File for all BMS-sponsored studies. This role involves delivering technical expertise in TMF and eTMF, supporting clinical trials throughout their lifecycle, and ensuring compliance with ICH/GCP guidelines. The ETMF Operations Analyst will play a critical role in maintaining inspection readiness and supporting quality review/validation activities.
Key Responsibilities
- Document Management:
- Upload and apply metadata to documents across all classifications in the eTMF.
- Ensure the quality and completeness of documents at the document level for all BMS-sponsored studies.
- Compliance and Quality Assurance:
- Monitor adherence to ICH/GCP guidelines, regulatory requirements, ALCOA+ principles, and BMS policies.
- Perform Quality Validation checks on documents post-Quality Review.
- Subject Matter Expertise:
- Serve as an SME for eTMF and the TMF Reference Model across all therapeutic areas and research phases.
- Collaborate with cross-functional, global teams to support clinical trial activities.
- Business Administration:
- Perform tasks associated with the eTMF Business Administrator role, including report generation, metrics tracking, and controlled document template management.
- User Acceptance Testing (UAT):
- Develop, execute, and review UAT scripts for eTMF changes/enhancements in collaboration with eTMF IT.
- Project Management:
- Apply project management principles to estimate time allocation and deliver on commitments.
- Communicate project status to team members and management.
- Continuous Improvement:
- Participate in reviewing and updating documents to reflect industry standards and regulatory requirements.
Qualifications
- Education:
- Minimum of a bachelor’s degree in a scientific or related discipline.
- Experience:
- 3-5 years of experience in eTMF, preferably using Veeva Vault eTMF.
- Clinical trial experience and a strong understanding of Good Clinical Practice (GCP) and Good Documentation Practices (GDP).
- Experience managing clinical content in a records management system or eTMF.
- Key Competencies:
- Extensive knowledge of ALCOA+ standards, ICH guidelines (E6(R2)), and regulatory requirements.
- Critical thinking and problem-solving skills.
- Strong verbal and written communication skills.
- Ability to manage multiple tasks in a fast-paced environment.
