Clinical Trial Results Manager

<p>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.</p><br><p><b>Key Responsibilities:</b></p><ul><li>Identifies result summary data to be disclosed based on the protocol and study report.</li><li>Creates the results reporting form for a clinical trial based on information found in the clinical study report.</li><li>Manages the review and approval process for the results form, uploads completed and approved forms to ClinicalTrials.gov and EudraCT/CTIS.</li><li>Partners with DQS and external partners to ensure AE xml files for results disclosure are created and uploaded to the database.</li><li>Files reporting extensions (certificates of delay) when appropriate.</li><li>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) </li><li>Provides operational support for other pillars of Clinical Trial Transparency, as needed</li><li>Assesses revised protocols for impact on registration, and works with the study team on registration updates.</li><li>Publishes CSR synopsis on BMS.com</li><li>Contributes to improvements of clinical trial data disclosure processes and related documentation.</li><li>Support Plain Language Summary (PLS) activities, as needed.</li></ul><br><ul><li> Requirements<ul><li>BS, MS, or PhD in scientific or medical field</li><li>Minimum of 3 years overall work experience</li><li>Demonstrated Excel and analytical skills</li><li>Bachelor’s degree in a life science field with 2+ years of technical or preferably scientific writing experience</li></ul></li><li><b>Ideal Candidates Would Also Have</b>: <ul><li>Work experience in quality, regulatory, compliance, clinical research or drug development, clinical research preferred</li><li>Familiarity with clinical trial protocols and reports desirable</li></ul></li></ul><br><p style="text-align:left !important">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.<br></p><p style="text-align:left !important"><b>How We Work</b></p><p>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 <a target="_blank" href="https://careers.bms.com/life-at-bms/ways-of-working/"><span style="color:#0875e1"><u>https://careers.bms.com/ways-of-working.</u></span></a></p><br><p><b>Supporting People with Disabilities</b></p><p>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 <a target="_blank" href="mailto:adastaffingsupport@bms.com"><span style="color:#0875e1"><u>adastaffingsupport@bms.com</u></span></a>. Visit <a target="_blank" href="https://careers.bms.com/eeo-accessibility"><span style="color:#0875e1"><u>careers.bms.com/eeo-accessibility</u></span></a> to access our complete Equal Employment Opportunity statement.</p><br><p><b>Candidate Rights</b></p><p>BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.</p><br><p>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: <a target="_blank" href="https://careers.bms.com/california-residents/"><span style="color:#0875e1"><u>https://careers.bms.com/california-residents/</u></span></a></p><br><p><b>Data Protection</b></p><p>We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at <a target="_blank" href="http://careers.bms.com/fraud-protection"><span style="color:#0875e1"><u>https://careers.bms.com/fraud-protection</u></span></a>.</p><br><p>Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.</p><p>If this posting is missing required information required by local law or incorrect, contact BMS at <a target="_blank" href="mailto:TAEnablement@bms.com"><span style="color:#0875e1"><u>TAEnablement@bms.com</u></span></a> 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.</p><p><br><br></p>R1607639 : Clinical Trial Results Manager