Job Details

Director, Clinical Data Management

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. The Director will partner closely with internal study teams, CROs, and external vendors to ensure clinical trial data are complete, reliable, timely, and fit for decision-making, while bringing a hands-on, solutions-oriented approach to program execution and data quality.

Job Responsibilities:

• 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

Skills and Knowledge:

• 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.

Basic 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.