Senior Director, Clinical Data Management
United StatesFull-TimeDirector
Salary247400 - 305600 USD per year
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Job Details
- Experience
- 15+ years of relevant experience, 8+ years of leadership experience
- Required Skills
- GCP
Requirements
- Bachelor’s degree or higher in life sciences, health informatics, computer science, or a related field
- 15+ years of relevant experience
- 8+ years of leadership experience in clinical data management within clinical trial environments
- Strong expertise in EDC systems
- Strong expertise in clinical data standards
- Strong expertise in data cleaning processes
- Strong expertise in 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
Responsibilities
- 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.
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