Clinical Trial Results Manager

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.
Key Responsibilities:
Identifies result summary data to be disclosed based on the protocol and study report.
Creates the results reporting form for a clinical trial based on information found in the clinical study report.
Manages the review and approval process for the results form, uploads completed and approved forms to ClinicalTrials.gov and EudraCT/CTIS.
Partners with DQS and external partners to ensure AE xml files for results disclosure are created and uploaded to the database.
Files reporting extensions (certificates of delay) when appropriate.
Liaises with Statisticians, Clinical Trial Physicians, Patent Attorneys, Global Trial Manager, and Medical Writers on all trials - operates as part of team to ensure the data best supports results and is consistent with other public forms of trial results (i.e. publication in a clinical journal)
Provides operational support for other pillars of Clinical Trial Transparency, as needed
Assesses revised protocols for impact on registration, and works with the study team on registration updates.
Publishes CSR synopsis on BMS.com
Contributes to improvements of clinical trial data disclosure processes and related documentation.
Support Plain Language Summary (PLS) activities, as needed.
Requirements
BS, MS, or PhD in scientific or medical field
Minimum of 3 years overall work experience
Demonstrated Excel and analytical skills
Bachelor’s degree in a life science field with 2+ years of technical or preferably scientific writing experience
Ideal Candidates Would Also Have:
Work experience in quality, regulatory, compliance, clinical research or drug development, clinical research preferred
Familiarity with clinical trial protocols and reports desirable
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.
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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/
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R1607639 : Clinical Trial Results Manager