Line Manager - Trial Master File (TMF) Study Lead

Line Manager, TMF Study 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: careers.bms.com/working-with-us.

Key Responsibilities:

• Supervisory responsibility for TMF Study Leads, provides training, support, and coaching as required.

• Oversee TMF activities for clinical trials to ensure compliance with filing and archiving requirements.

• Oversee TMF Archiving activities, including end of study Patient Data Reports (PDR) generation and distribution, and CRO TMF transfer activities to ensure compliance with TMF archiving procedures.

• In collaboration with the TMF Study Leads, supports BMS audit/inspection readiness activities, and consults with all relevant functions within and outside GDO to ensure readiness.

• Support the TMF Process Leads to develop and implement various TMF process optimization initiatives to monitor and achieve quality and compliance of key process controls.

• Provides leadership, infrastructure, and subject matter expertise to the TMF organization.

• Monitors the clinical book of work to ensure resources are assigned appropriately, with precedence given to trials assigned priority status.

• Responsible for development of internal staff to strengthen the TMF organization.

• Collaborates across multiple functions supporting clinical trial processes to ensure adherence to internal process controls and regulatory requirements for efficient and compliance maintenance and archival of TMFs.

• Supports TMF process training for internal and CRO teams.

• Maintains a contemporary knowledge of regulatory requirements and industry trends, as they relate to the TMF process.

• Communicate as appropriate with relevant stakeholders, internal and external.

• Along with TMF Process Leads, participate and lead continuous improvement initiatives relating to clinical trial documentation and TMF compliance.

• Address gaps in TMF compliance as surfaced by internal quality metrics, KPIs, proactive risk assessments, independent business monitoring, and inspections.

Qualifications

• Minimum of bachelor's degree in a scientific or related discipline.

• Strong leadership and people management skills.  Able to set ambitious goals for self and team.

• Extensive knowledge and application of ALCOA+ standards, Good Clinical Practice, Good Documentation Practices, and International Council for Harmonization guidelines (ICH-E6)

• Ability to prioritize work and assess risk to meet the needs of the organization. 

• Demonstrated ability to work independently and seek out support when needed. 

• Adaptable and able to modify personal and organizational work style to meet the needs of the business. 

• Exceptional written and oral communication skills.  Experienced in facilitating tailored presentations to stakeholder groups. Highly motivated and passionate about continuous learning and organizational development.

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.

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

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/

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 you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1598934 : Line Manager, TMF Study Lead

Experience Level

Senior Level