Director, Clinical Data Management

Role Description

The Director, Clinical Data Management will serve as the Clinical Data Management program lead for a new product, providing end-to-end data management leadership across the program’s clinical studies. This role will be accountable for driving data management strategy, execution, quality oversight, and cross-functional alignment from study start-up through database lock, submission support, and inspection readiness.

• Serve as the Clinical Data Management program lead for a new product and lead the individual studies within that program, providing strategic and hands-on data management leadership from study start-up through database lock.
• Develop and drive the data management strategy for the assigned new-product program, including study start-up planning, database build oversight, data review approach, risk management, database lock, and submission readiness.
• Lead data management execution at both the program and study level in partnership with study teams, ensuring high-quality, timely, and decision-ready clinical trial data across all studies within the program.
• Oversee CROs and data management vendors supporting the program and its studies, ensuring clear expectations, accountability, quality, compliance, and adherence to study and program timelines.
• Partner cross-functionally with Biostatistics, Statistical Programming, Clinical Operations, Medical Monitoring, Safety, Regulatory Affairs, and other stakeholders to align on program priorities, data quality expectations, and deliverables.
• Lead ongoing cross-functional data review activities and ensure timely identification, escalation, and resolution of data issues, trends, risks, and quality concerns.
• Oversee or contribute to key data management documentation, including Data Management Plans, edit check specifications, validation plans, reconciliation plans, data transfer agreements, data review plans, and database lock documentation.
• Willing to travel approximately 10% of the time. Evening and weekend work may be required.
• Leverages AI to drive program, portfolio, or functional performance through prioritization and scaled adoption.

Qualifications

• 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.

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 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 is required.
• Proven ability to manage CRO relationships and oversee data management deliverables.
• Experience utilizing AI-enabled tools to improve productivity and work efficiency.

Preferred Requirements

• Radiopharmaceutical experience preferred.

Physical Demands

• While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear.
• The employee must occasionally lift and/or move up to 20 pounds.
• Specific vision abilities required by this job include close vision and distance vision.

Work Environment

• The noise level in the work environment is usually moderate.

Compensation Overview

• Remote - United States - US: $200,980 - $243,544
• San Diego - RayzeBio - CA: $217,060 - $263,021

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).
• Additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, and leaves of absence for various needs.