Sr. Manager, TMF Process Lead

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.