Associate Director, Clinical Data Management

🕒 August 5

🇺🇸 United States – Remote

💵 $173.2k - $209.9k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 22%

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Bristol Myers Squibb

WebsiteLinkedInAll Job Openings

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

• Provide data management leadership, insight, and support to internal and external projects and clinical trials • Serve as lead Clinical Data Manager for multiple clinical trials simultaneously when required • Ensure collected data meets study objectives and company quality standards • Manage and oversee data management personnel and CRO/vendor activities • Ensure CRO adherence to project timelines from study startup through study closeout • Participate in cross-functional meetings and provide updates on project status, issues, and milestones • Review data using listings and visualization tools for performance and quality reporting • Conduct reviews within and across studies for trend analysis • Lead interactions with third-party vendors, including clinical laboratories, regarding study-specific data collection, transmittal, and transfer • Contribute to SOP development and updates for regulatory compliance and operational needs • Apply AI to improve team execution and decision-making

🎯 Requirements

• Bachelor’s degree • Minimum of 6 years of data management experience in pharmaceutical/biotech/CRO industry • Extensive hands-on experience in all aspects of data management • Bachelor’s degree in Life Science, mathematics, or health-related fields (preferred) • Experience in the Oncology therapeutic area (preferred) • Proven ability to manage CRO relationships and oversee data management deliverables • 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 • Proficiency in clinical systems, including EDC, IVRS, CTMS, eTMF, and other clinical project management tools • Willingness/ability to travel 10%

🏖️ Benefits

• Additional discretionary incentive cash and stock opportunities • Wellbeing support • Retirement and financial protection benefits • Medical, dental, vision, life and disability insurance offerings • Flexible Time Off (FTO) for U.S.-based exempt employees • 11 paid company holidays each year • 160 hours of paid vacation annually for new hires for non-exempt employees, RayzeBio employees, and employees located in Puerto Rico • 3 optional holidays for non-exempt employees, RayzeBio employees, and employees located in Puerto Rico • Paid sick leave, depending on eligibility • Up to two paid volunteer days per year • Summer hours flexibility • Leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs • Annual Global Shutdown between Christmas Day and New Year's Day for eligible employees • Reasonable workplace accommodations/adjustments and ongoing support for people with disabilities