Director, Clinical Data Management

🔥 0 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $210.6k - $255.2k / year

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

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Bristol Myers Squibb

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1887

🧬 Biotechnology

💊 Pharmaceuticals

Biotechnology • Pharmaceuticals

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

• Lead the Clinical Data Management function at RayzeBio, providing strategic and operational oversight across the clinical portfolio. • Serve as the Data Management lead for a high-priority clinical development program, maintaining hands-on involvement in study execution, data review, issue resolution, and risk management. • Provide leadership for NDA/BLA submission activities, including submission readiness, data standards compliance, and regulatory inspection preparedness. • Partner cross-functionally with Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, Safety, and Regulatory Affairs to support study execution and data quality objectives. • Oversee CROs and vendors, ensuring quality, compliance, accountability, and adherence to timelines and deliverables. • Lead ongoing cross-functional data review activities and oversee the development of key data management documentation, including Data Management Plans, edit checks, validation specifications, reconciliation plans, and data transfer agreements. • Develop and implement scalable data management processes, standards, governance, and SOPs to support operational excellence and organizational growth. • Manage competing priorities across multiple studies while proactively identifying operational risks and mitigation strategies. • Build, develop, and expand the Clinical Data Management team, and foster a collaborative and high-performing team environment. • Willing to travel approximately 10% of the time. Evening and weekend work will be involved.

🎯 Requirements

• Bachelor’s or Master’s degree in Life Sciences, Computer Science, Mathematics, Health Sciences, or a related field required. • Minimum of 10 years data management experience in pharmaceutical/biotech/CRO industry. • Demonstrated experience in team leadership and management. • Ability to guide, mentor, and develop team members. • In-depth experience in the Oncology therapeutic area is 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 (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.

🏖️ Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care. • Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). • Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support. • Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.