Sr. Manager, TMF Process Lead

Working with Us

Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: .

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 (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).

Qualifications:

Education/Degree(s):

• Bachelor'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.

Travel:

• Occasional

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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 . Visit eeo -accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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

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