Clinical Trial Results Manager

• 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

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: • 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.