Director, Clinical Data Management

This is a fully remote position, open to applicants in California.

📋 Description

• Act as the Clinical Data Management program leader for a new product, overseeing studies from initiation to database lock.

• Formulate and implement a data management strategy that encompasses study start-up planning, database construction supervision, data evaluation, risk management, database lock, and submission readiness.

• Direct program-level and study-level data management activities to provide high-quality, timely, and decision-ready clinical trial data.

• Supervise CROs and data management vendors, ensuring accountability, quality, compliance, and adherence to deadlines.

• Collaborate with Biostatistics, Statistical Programming, Clinical Operations, Medical Monitoring, Safety, Regulatory Affairs, and other relevant stakeholders.

• Facilitate cross-functional data reviews, identifying, escalating, and resolving data issues, trends, risks, and quality concerns.

• Oversee or assist in the preparation of Data Management Plans, edit check specifications, validation plans, reconciliation plans, data transfer agreements, data review plans, and database lock documentation.

• Utilize AI to enhance program, portfolio, or functional performance through prioritization and broad adoption.

• Travel around 10% of the time; evening and weekend work may be necessary.

⛳️ Requirements

• A Bachelor’s or Master’s degree in Life Sciences, Computer Science, Mathematics, Health Sciences, or a related discipline is required.

• At least 10 years of experience in data management within the pharmaceutical, biotech, or CRO sectors.

• Proven experience in leading study teams, vendors, or managing direct/indirect reports.

• Capability to guide, mentor, and develop team members as needed.

• Extensive experience in the Oncology therapeutic area is a must.

• Demonstrated ability to oversee CRO relationships and manage data management deliverables effectively.

• Familiarity with AI-enabled tools to enhance productivity and work efficiency.

• Strong knowledge and experience with EDC systems, particularly Medidata RAVE or Veeva.

• Comprehensive understanding of GCP, CDISC/CDASH data structures, ICH guidelines, and FDA regulations.

• Exceptional verbal and written communication skills.

• Strong analytical and problem-solving capabilities.

• Experience in radiopharmaceuticals is preferred.

🏝️ Benefits

• Additional incentive cash and stock opportunities (dependent on eligibility).

• Comprehensive medical, pharmacy, dental, and vision care.

• BMS Well-Being Account.

• BMS Living Life Better program.

• Employee Assistance Programs (EAP).

• 401(k) retirement plan.

• Short- and long-term disability insurance.

• Life insurance coverage.

• Accident insurance.

• Supplemental health insurance options.

• Business travel protection.

• Personal liability protection.

• Identity theft protection benefits.

• Legal support services.

• Survivor support programs.

• Flexible time off for eligible US exempt employees, subject to manager approval.

• 11 paid national holidays.

• 160 hours of annual paid vacation for eligible RayzeBio exempt, non-exempt, and hourly employees, with manager approval.

• 3 optional holidays.

• Unlimited paid sick time (based on eligibility).

• Up to 2 paid volunteer days annually.

• Summer hours flexibility (based on eligibility).

• Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs.

• Annual Global Shutdown between Christmas and New Year's Day.

• Reasonable workplace accommodations/adjustments and ongoing support.