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.

- Lead and manage strategic collaboration between BMS and CROs to ensure adherence to TMF processes and regulatory compliance, serving as the primary liaison for all TMF compliance matters.

- 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 (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).

Qualifications:

Education/Degree(s): Degree in a related field, such as life sciences, computer science, or business administration.

Experience:

- Minimum of 7+ 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.