Senior Director, Clinical Data Management at Jobgether – United States

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Senior Director, Clinical Data Management in the United States.

This senior leadership role is responsible for shaping and executing the clinical data management strategy across a growing portfolio of oncology-focused clinical trials. You will ensure the integrity, quality, and regulatory readiness of all clinical study data from protocol design through database lock and submission. Acting as both a strategic leader and hands-on expert, you will oversee data management activities across internal stakeholders and external vendors in a fast-paced biotech environment. The role plays a critical part in enabling high-quality, analysis-ready datasets that support clinical, statistical, and regulatory decision-making. You will collaborate closely with cross-functional teams including Clinical Operations, Biostatistics, Regulatory Affairs, and Translational Medicine. This position also involves building scalable data management capabilities and processes to support an expanding clinical pipeline. It offers high visibility and the opportunity to directly impact the success of innovative cancer therapies.

Lead and oversee all clinical data management activities across clinical development programs, ensuring high-quality, timely, and regulatory-compliant data delivery.

• Serve as the primary clinical data management leader for assigned studies, ensuring data quality, inspection readiness, and timely database lock from protocol design through study completion.
• Perform detailed protocol review to ensure optimal data capture strategy, endpoint alignment, and downstream statistical usability.
• Lead CRF design and review, ensuring consistency with protocols, SAPs, and regulatory expectations.
• Develop, review, and approve key data management documentation including DMPs, database specifications, edit check specifications, and data review plans.
• Oversee EDC system setup, validation, UAT, and ongoing system change control activities.
• Conduct hands-on data review, query management, and trend analysis to ensure proactive data cleaning and high-quality datasets.
• Manage and oversee CROs and external vendors delivering clinical data management services, including performance tracking and issue escalation.
• Ensure compliance with GCP, ICH guidelines, and CDISC standards across all clinical data activities.
• Support inspection readiness, audits, and regulatory submissions through documentation and direct engagement with findings.
• Partner with cross-functional teams to align data strategies with clinical execution, statistical analysis, and regulatory requirements.
• Contribute to study-level and program-level governance discussions as the data management subject matter expert.
• Drive continuous improvement of data management processes, tools, SOPs, and system capabilities.
• Support vendor selection, budgeting, and implementation of clinical data systems such as EDC, IRT, and eCOA solutions.

This role requires extensive experience in clinical data management within biotech or pharmaceutical environments, along with strong leadership and vendor oversight capabilities.

• Bachelor’s degree or higher in life sciences, health informatics, computer science, or a related field, with 15+ years of relevant experience.
• 8+ years of leadership experience in clinical data management within clinical trial environments.
• Strong expertise in EDC systems, clinical data standards, data cleaning processes, and regulatory expectations (GCP, ICH, CDISC).
• Proven experience managing CROs and external vendors delivering clinical data services.
• Deep understanding of clinical trial operations and cross-functional drug development processes.
• Strong ability to lead in a matrixed, fast-paced biotech environment while managing multiple priorities.
• Excellent communication, collaboration, and stakeholder management skills.
• Hands-on mindset with the ability to contribute directly to technical data management activities.
• Preferred experience in oncology and/or cell and gene therapy programs.
• Experience supporting regulatory submissions and inspection readiness activities is highly desirable.

• Competitive salary range: $247,400 – $305,600
• Medical, dental, and vision insurance coverage
• 401(k) retirement plan with 100% employer match up to 4% contribution
• Generous paid time off and paid holidays
• Employee commuter benefits and cell phone stipend
• Fully remote flexibility within the United States (with occasional onsite travel if remote)
• Opportunity to contribute to innovative oncology and immunotherapy programs
• High-impact leadership role in a fast-growing biotech environment
• Exposure to cutting-edge clinical development and regulatory initiatives