Senior Manager, TMF Process Lead

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 eTMF.
• Preference to experience with project management methodologies and tools.
• Thorough understanding of ALCOA+ standards, Good Clinical Practice and Good Documentation practices and ICH guidelines, and applicable local regulatory requirements.
• Must have a strong understanding of the primary clinical business systems utilized for TMF process.
• Extensive knowledge of clinical trial documentation and TMF management activities, including a strong technical understanding of Vault eTMF system.
• Strong working knowledge of TMF and technical knowledge of Vault eTMF and clinical document management systems.
• Comprehensive knowledge of local and international regulatory guidelines/requirements pertinent to TMF management.
• Demonstrated ability to create/provide TMF-related training and coaching to a broad range of stakeholders.

Skills/Abilities:

• Excellent teamwork, interpersonal, and communication skills, with the ability to communicate and collaborate with employees and management at all levels and through various formats.
• Demonstrated ability to work in a matrixed organization with a range of technically, culturally, and geographically diverse teams and to influence areas not under direct control to achieve objectives.
• Strong analytical and problem-solving skills, with the ability to identify and resolve complex issues.
• Ability to work independently and manage multiple priorities in a fast-paced environment.

Travel:

Occasional