Etmf Specialist

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.

• Responsible for managing and executing centralized activities supporting global trials with responsible emphasis on clinical documentation.
• Upload and perform a rigorous quality reviews of electronic documents residing in the eTMF system to ensure they are inspection-ready and are compliant with the ALCOA Plus principles.
• Apply filing attributes/metadata as appropriate/required to documents to facilitate classification, management, identification, and accessibility to retrieve files.
• Provide immediate feedback for any quality Issue findings.
• Interact with regional roles, the study team and other functional areas within BMS to manage document quality, timeliness and completeness and provide support to the study team throughout the study duration (start-up, maintenance, and close-out of clinical studies).
• Develops and maintains collaborative working relationships with clinical study teams.
• Review of essential regulatory documentation, including submission of final documents to the eTMF.
• May provide a level of quality control of start-up activities.
• Act as single point of contact for the study team for centralized activities related to document management.
• Ongoing maintenance and tracking of essential records and collection of updated/outstanding documentation.
• Proactively resolve issues related to missing or expired documents.
• Ongoing communication with study teams regarding centralized document management activities.
• Other duties as assigned to support Clinical Trials.

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 [email protected]. 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 [email protected] 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.

R1608032 : Etmf Specialist