Sr. Manager, TMF Process Lead – Clinical Operations
Location: Hyderabad, Telangana, India
Experience Required: 7+ Years
Job Type: Full-Time
Job ID: R1596349
About Bristol Myers Squibb (BMS)
Bristol Myers Squibb (BMS) is a global biopharmaceutical company dedicated to transforming patients’ lives through science™. BMS develops innovative therapies across oncology, immunology, cardiovascular, and other therapeutic areas. The company fosters a collaborative, inclusive, and innovative culture, empowering employees to grow professionally while driving excellence in clinical operations worldwide.
Position Overview
The Sr. Manager, TMF Process Lead provides strategic leadership for Trial Master File (TMF) processes and eTMF operations. This role ensures regulatory compliance, process optimization, and inspection readiness for clinical studies globally. The position serves as a subject matter expert (SME), guiding TMF governance, training, technical enhancements, and cross-functional collaboration.
Key Responsibilities
Leadership & Governance
Act as TMF Subject Matter Expert within governance committees and cross-functional teams.
Drive process optimization, quality governance, and continuous improvement for TMF and archival processes.
Represent TMF and eTMF operations in leadership panels, meetings, and audits.
Training & Coaching
Develop training materials, templates, job aids, and plans for TMF and archival operations.
Provide coaching to eTMF Operations Analysts, TMF Study Leads, Archive Leads, Specialists, and CRO/FSP teams.
Process Development & Compliance
Develop, maintain, and update SOPs, Work Instructions, and procedural documents for TMF and archival processes.
Oversee compliance activities, including patient data reporting, CRO TMF transfers, and document management.
Implement technical enhancements, automation, and innovative solutions for eTMF to improve quality and compliance oversight.
Collaboration & Stakeholder Management
Communicate and coordinate with internal and external stakeholders to ensure TMF compliance and inspection readiness.
Serve as primary liaison between BMS and CROs, promoting adherence to TMF processes and regulatory standards.
Consult cross-functionally to identify opportunities for process efficiency and control improvements.
System & Technical Oversight
Provide technical leadership for eTMF and archival systems, including Vault Clinical/Veeva CTMS/eTMF.
Identify system gaps, implement enhancements, and ensure accurate reporting through KPIs and metrics.
Lead and support TMF audits and inspection activities, ensuring readiness and compliance.
Continuous Improvement
Lead initiatives to optimize TMF processes, document management, and archival compliance.
Monitor performance, address gaps, and ensure corrective actions are implemented effectively.
Required Qualifications & Skills
Education:
Bachelor’s degree in Life Sciences, Computer Science, Business Administration, or a related field. Advanced degree is a plus.
Experience:
Minimum 7+ years in clinical development operations, with a focus on eTMF and clinical documentation.
Strong knowledge of ALCOA+ standards, GCP, Good Documentation Practices, ICH guidelines, and applicable local regulatory requirements.
Hands-on experience with Vault eTMF, CTMS, and clinical document management systems.
Experience in training, coaching, and cross-functional collaboration.
Skills & Abilities:
Excellent communication, interpersonal, and collaboration skills with diverse teams.
Ability to influence and lead in a matrixed, multi-cultural, global environment.
Strong analytical and problem-solving skills, with ability to manage multiple priorities.
Proactive, independent, and adaptable in a fast-paced clinical operations environment.
Travel:
Occasional domestic and international travel may be required.
Why Join BMS
Lead global TMF and eTMF operations impacting clinical trial quality and regulatory compliance.
Collaborate with cross-functional and international teams on strategic initiatives.
Drive continuous improvement, innovation, and inspection readiness.
Build a career in a highly respected, patient-focused global biopharmaceutical organization.
Equal Opportunity & Accessibility
BMS is committed to diversity, equity, and inclusion. Applicants with disabilities may request reasonable accommodations during recruitment. The application process is secure; BMS will never request payments or financial information.
Apply Now to advance your career while contributing to global clinical trial excellence and patient-focused outcomes.
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