At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.
Position Summary
The TMF Process Lead reports into the TMF Compliance Lead and provides leadership and subject matter expertise within the TMF governance structure and support framework, driving process optimization and quality oversight for clinical studies. This role develops and delivers training and support for both internal teams and external partners, ensuring consistent understanding and application of TMF processes.
Key responsibilities include creating and maintaining procedural documentation, overseeing compliance activities, and implementing process improvements, including through innovation and automation. The TMF Process Lead collaborates widely with stakeholders to ensure inspection readiness and regulatory compliance, while also providing technical leadership for TMF systems and monitoring performance metrics.
Continuous improvement is central to the role, with active participation in audits and associated quality and compliance initiatives to address process and control gaps and ensure effective TMF management and archiving for the BMS clinical book of work.
Duties/Responsibilities
Leadership & Governance
Provides leadership within the TMF governance structure, acting as Subject Matter Expert for process groups and within cross-functional teams.
Supports process optimization, continuous improvement, and quality governance for active studies.
Represents TMF Process and eTMF Operations at meetings and leadership panels.
Training & Coaching
Develops training materials, templates, job aids, plans, etc… for TMF and archival processes.
Provides training, support, and coaching for eTMF Operations Analysts, TMF Study Leads, Archive Leads, and Specialists (including CRO/FSP teams), on TMF processes and operating models.
Process Development & Documentation
Develops, updates, and maintains Procedural Documents, SOPs, Work Instructions, etc… for TMF and archival processes and operations.
Oversees compliance activities for TMF and archiving, including Patient Data Report generation, distribution and CRO TMF transfers.
Implements technical enhancements to eTMF, including innovation and automation, for improved quality and compliance oversight.
Collaboration & Stakeholder Engagement
Communicates and coordinates with internal and external stakeholders to ensure TMF compliance and inspection readiness.
Collaborates and consults multifunctionally to promote and support business and regulatory compliance and to identify opportunities to increase process and control efficiency.
System & Technical Oversight
Provides technical leadership for eTMF operations and archival systems (e.g., Vault Clinical/Veeva CTMS/eTMF).
Identifies and addresses technical gaps in TMF systems.
Develops and monitors KPIs and metrics for TMF and archival compliance.
Continuous Improvement & Compliance
Leads and participates in continuous improvement initiatives related to TMF management, archival and compliance.
Addresses process compliance and performance gaps, as highlighted by quality metrics and KPIs.
Leads and participates in TMF audits and inspection activities (readiness, preparedness, and management).
Reporting Relationship
Reports to the TMF Compliance Lead
Qualifications
Education/Degree(s):
Bachelor's degree in a related field, such as life sciences, computer science, or business administration.
Experience:
Minimum of 5 years of experience in clinical development operations, with a focus on…