Job Description

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 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

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

For roles based in Washington State only: If you live in or expect to work from Washington State if hired for this position, please visit this page for important information about the Washington Fair Chance Act.

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If this posting is missing required information required by local law or incorrect, contact BMS at TAEnablement@bms.com with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1607965 : Sr. Manager, TMF Process Lead