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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.

Position Summary:

The Local TMF Process Lead reports into the Global TMF Process Lead (GPL) and will support GPL in creating/achieving TMF Process optimization and robust TMF infrastructure for active studies.

This role (Local TMF Process Lead) provides leadership support in development of key TMF processes and supports maintaining coordination with Contract Research Organization (CRO) partners to ensure TMF compliance and inspection readiness for active studies.

Responsibilities :

• Provides leadership support, infrastructure, and subject matter expertise to the TMF process group and cross functional organization.

• Provides training, support, and coaching as required to TMF Study Leads and CW/FSPs on TMF processes and multiple TMF operating models.

• Provide leadership support in developing TMF Process related Job Aids, templates, and plans. Attend/represent the Global TMF Process Lead at key meetings.

• Serve as Key member of TMF leadership team and attend multiple leadership panels.

• Supports BMS TMF audit/inspection of active studies and TMF related readiness activities, consults with all relevant functions as needed within and outside GDO to ensure readiness.

• Support Global TMF Process Lead in creating and maintaining BMS-CRO Partnership plans for preferred CROs, attending monthly BMS-CRO meetings and overseeing TMF execution by CRO for active studies outsourced to CRO.

• Collaborate with Global TMF Process Lead and Global TMF Process Owner/Leads in developing and updating TMF procedural documents, SOP (Standard Operating Procedure) and Work Instructions.

• Support the Global TMF Process Lead in developing & implementing various TMF Process Initiatives to achieve quality and compliance.

• Represent TMF Process in eTMF system functionalities discussion and as needed development of KPIs (Key Performance Indicators) and metrics for eTMF users.

• Collaborates across multiple functions supporting clinical trial processes to ensure adherence to regulatory requirements for maintenance of compliant TMFs and identify efficiency opportunities.

• Assists and trains internal and CRO teams on TMF processes.

• Maintains continuous knowledge of the regulatory requirements and industry trends related to TMF compliance.

• Communicate as appropriate with relevant stakeholders.

• Address gaps in TMF compliance as highlighted by Quality metrics and KPIs.

• Lead and participate in continuous improvement initiatives related to TMF management and compliance.

• Partner with other TMF Leaders and SMEs as needed.

Requirements:

• Minimum of a bachelor’s degree in science, Pharmacy, or related field; equivalent work experience in the TMF space (5 - 7 years)

• 5 – 7 years of experience in TMF/eTMF and understanding of process leadership.

• Experience with independently managing projects, multitasking in fast paced environment, and delivering results within tight timelines.

• Strong working knowledge of TMF and technical knowledge of Vault eTMF and clinical document management systems.

• Strong organizational and technical ability. Demonstrated Excel, PowerPoint, and SharePoint skills.

• 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.

• Extensive knowledge of clinical trial documentation and TMF Management activities

• Thorough understanding of ALCOA+ standards, Good Clinical Practice, Good documentation practice and applicable local regulatory requirements.

• Exceptional written and oral communication skills.

• Experienced in facilitating tailored presentations to cross-functional stakeholder groups.

• Initiative-taking and enthusiastic about continuous learning and organizational development.

• Strong technical understanding of Vault eTMF system.

• Effective communication and interpersonal skills, verbal and written.

• Strong leadership with ability to set ambitious goals for self and others.

• 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.

• Strong analytical, problem-solving and critical thinking skills.

#LI-Hybrid

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 an inclusive culture, promoting diversity 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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

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.

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.

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

Bristol Myers Squibb is a leading global biopharma company focused on discovering, developing and delivering innovative medicines for patients with serious diseases in areas including oncology, hematology, immunology, cardiovascular, fibrosis and neuroscience. Our employees work every day to transform patients’ lives through science.