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

This position provides subject matter expertise in clinical business systems supporting TMF processes, working closely with process owners, leads and functional stakeholders to ensure systems are fit for purpose to represent the needs of end users, and are operated according to established procedures.  To support these aims this position is responsible for creating and maintaining process documentation, supporting compliance activities such as internal business monitoring, clinical auditing and inspection readiness, and managing system-related issues with members of the TMF team and in collaboration with broader R&D, including Global Development Operations, R&D IT, and associated vendors and consultants, to deliver efficient and effective TMF processes.

Duties/Responsibilities

• Provide subject matter expertise in the utilization of clinical business systems to promote TMF process and regulatory compliance .
• Align with process owners to ensure utilization of our clinical business systems is conducted in accordance with established processes and procedures.
• Align within functional stakeholders to represent the end-user needs of TMF to the R&D IT organization including business strategy, business requirements, user testing, and implementation of new systems and enhancements.
• Collaborate with cross-functional teams, including global development operations, R&D IT, and vendors, to ensure that TMF processes are conducted efficiently and effectively.
• Provide final business, regulatory, and administrative approvals per applicable SOPs.
• Actively participate in multiple aspects of User Acceptance Testing including scenario planning, scripting, and coordination with business users.
• Create and maintain applicable process and workflow documentation, in collaboration with process owners and process leads.
• Serve as a point of contact for compliance related activities including clinical auditing, inspection readiness, preparedness and support, finding assessments, corrective and preventive action development and delivery, and data integrity and audit trails reviews.
• Collaborate with R&D IT organization for activities such as active management of super user network, troubleshooting issues across capabilities.

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.
• Must have a strong understanding of the primary clinical business systems utilized for TMF process.

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.

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