Director, Clinical Data Management

Role Summary

Director of Clinical Data Management (CDM) to lead study-level data management activities in support of oncology clinical development programs. Serve as the CDM lead for one or more clinical trials, responsible for planning, execution, and oversight of data management in collaboration with internal stakeholders and external partners. May evolve to include line management responsibilities.

Responsibilities

• Work closely with Clinical Operations, Biostatistics, Medical, and Regulatory Affairs to align on trial objectives, timelines, and data expectations.
• Act as the data management point-of-contact during study planning, conduct, and closeout phases.
• Lead Data Working Groups and cross-functional data review meetings and ensure data quality is maintained throughout the study.
• Contribute to the development of clinical trial protocols and statistical analysis plans (SAPs) from a data management perspective.
• Collaborate with and provide oversight of ex-US DM collaborators, CROs and third-party vendors, ensuring the quality and timeliness of deliverables.
• Participate in vendor selection and contracting activities; contribute to the development of vendor performance metrics.
• Ensure effective communication between vendors and internal teams to address data-related issues.
• Contribute to the development and continuous improvement of data management processes, SOPs, and standards within the organization.
• Support regulatory inspections and audits by providing documentation and subject matter expertise as needed.
• May lead or participate in data-focused initiatives, such as implementing new data review tools and R shiny apps, standardizing data review workflows, or adopting novel data sources (e.g., ePRO, wearables).
• As the team grows, provide mentorship or line management to junior CDM staff or contractors; participate in training and onboarding of new team members.

Qualifications

• Bachelor‚Äôs degree in life sciences, data science/statistics/math, computer science, health informatics, or related field required; advanced degree preferred.
• 8+ years of clinical data management experience in biotech, pharmaceutical, or CRO industry.
• 3+ years leading data management activities for global clinical trials (oncology experience highly preferred).
• Strong working knowledge of clinical data systems (preferably Medidata Rave) and CDISC standards (SDTM, CDASH).
• Experience managing third-party vendors and overseeing outsourced data management activities.
• Thorough understanding of GCP, ICH, and relevant regulatory guidelines.
• Excellent organizational, communication, and problem-solving skills.
• Ability to work in a fast-paced, hands-on environment; startup/small biotech experience desirable.
• Familiarity with complex data types (e.g., imaging, genomics, digital endpoints) in oncology trials is desirable.
• Demonstrated ability to balance strategic thinking with hands-on execution.
• Experience supporting regulatory submissions (e.g., NDA, BLA) is a plus.

Skills

• Problem-solving, stakeholder management, and strong communication
• Data management process improvement and SOP development
• Vendor oversight and collaboration
• Regulatory knowledge and submission support

Education

• Bachelor‚Äôs degree required; advanced degree preferred.

Additional Requirements

• None beyond standard job requirements.