Bristol Myers Squibb
10,000+ employees
Founded 1887
🏥 Healthcare
💼 Consulting
📦 Logistics
Healthcare • Consulting • Logistics
Bristol Myers Squibb is a global biopharmaceutical company that is dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. Their areas of focus include cardiovascular health, cell therapy, immunology, and oncology. With a commitment to transforming patient outcomes through pioneering science, Bristol Myers Squibb partners with a worldwide network of researchers, healthcare providers, and other stakeholders. They aim to lead in innovation for patients while fostering diversity and inclusion within their workforce.
Director, Clinical Data Management
🕒 August 5
🏄 California – Remote
💵 $201k - $243.5k / year
⏰ Full Time
🔴 Lead
👨⚕️ Medical Director
🦅 H1B Visa Sponsor
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Bristol Myers Squibb
10,000+ employees
Founded 1887
🏥 Healthcare
💼 Consulting
📦 Logistics
Healthcare • Consulting • Logistics
Bristol Myers Squibb is a global biopharmaceutical company that is dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. Their areas of focus include cardiovascular health, cell therapy, immunology, and oncology. With a commitment to transforming patient outcomes through pioneering science, Bristol Myers Squibb partners with a worldwide network of researchers, healthcare providers, and other stakeholders. They aim to lead in innovation for patients while fostering diversity and inclusion within their workforce.
📋 Description
• Serve as the Clinical Data Management program lead for a new product and lead individual studies from study start-up through database lock • Develop and drive data management strategy, including study start-up planning, database build oversight, data review, risk management, database lock, and submission readiness • Lead program- and study-level data management execution to deliver high-quality, timely, decision-ready clinical trial data • Oversee CROs and data management vendors, ensuring accountability, quality, compliance, and adherence to timelines • Partner with Biostatistics, Statistical Programming, Clinical Operations, Medical Monitoring, Safety, Regulatory Affairs, and other stakeholders • Lead cross-functional data reviews and identify, escalate, and resolve data issues, trends, risks, and quality concerns • Oversee or contribute to Data Management Plans, edit check specifications, validation plans, reconciliation plans, data transfer agreements, data review plans, and database lock documentation • Leverage AI to drive program, portfolio, or functional performance through prioritization and scaled adoption • Travel approximately 10% of the time; evening and weekend work may be required
🎯 Requirements
• Bachelor’s or Master’s degree in Life Sciences, Computer Science, Mathematics, Health Sciences, or a related field required • Minimum of 10 years of data management experience in the pharmaceutical, biotech, or CRO industry • Demonstrated experience leading study teams, vendors, or direct/indirect reports • Ability to guide, mentor, and develop others as applicable • In-depth experience in the Oncology therapeutic area required • Proven ability to manage CRO relationships and oversee data management deliverables • Experience utilizing AI-enabled tools to improve productivity and work efficiency • Strong knowledge and experience of EDC systems, including Medidata RAVE or Veeva • Solid knowledge of GCP, CDISC/CDASH data structures, ICH guidelines, and FDA regulations • Excellent verbal and written communication skills • Strong analytical and problem-solving abilities • Radiopharmaceutical experience preferred
🏖️ Benefits
• Additional incentive cash and stock opportunities (based on eligibility) • Medical, pharmacy, dental, and vision care • BMS Well-Being Account • BMS Living Life Better • Employee Assistance Programs (EAP) • 401(k) plan • Short- and long-term disability insurance • Life insurance • Accident insurance • Supplemental health insurance • Business travel protection • Personal liability protection • Identity theft benefit • Legal support • Survivor support • Flexible time off for eligible US exempt employees, with manager approval • 11 paid national holidays • 160 hours annual paid vacation for eligible RayzeBio exempt, non-exempt, and hourly employees, with manager approval • 3 optional holidays • Unlimited paid sick time (eligibility-based) • Up to 2 paid volunteer days per year • Summer hours flexibility (eligibility-based) • Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs • Annual Global Shutdown between Christmas and New Years Day • Reasonable workplace accommodations/adjustments and ongoing support
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