Senior Director, Clinical Data Management
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Umoja BiopharmaBiotechnology, Pharmaceutical
Remote within the USFull-TimeDirector
Salary247400 - 305600 USD per year
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Job Details
- Experience
- 15 years of experience; 8+ years of leadership of data management functions for clinical trials
- Required Skills
- GCP
Requirements
- Bachelor’s degree or higher in life sciences, health informatics, computer science, or a related discipline.
- Minimum of 15 years of experience in clinical data management.
- 8+ years of leadership experience in data management functions for clinical trials.
- Demonstrated experience overseeing CROs and external vendors delivering clinical data management services.
- Strong working knowledge of clinical trial processes.
- Strong working knowledge of EDC systems.
- Strong working knowledge of data standards.
- Strong working knowledge of regulatory expectations for clinical data.
- Proven ability to lead teams and manage complex programs.
- Ability to collaborate effectively in a fast-paced, matrixed environment.
- Excellent written and verbal communication skills.
- Experience supporting oncology and/or cell or gene therapy clinical development programs (preferred).
- Experience building or scaling clinical data management capabilities in a growing biotech organization (preferred).
- Prior involvement in regulatory submissions and inspection readiness activities (preferred).
Responsibilities
- Serve as the primary clinical data management lead for assigned clinical trials, with direct accountability for data quality, timeliness, and inspection readiness from protocol development through database lock.
- Perform detailed protocol review with a focus on data flow, endpoints, data collection strategy, and facilitation of downstream analysis requirements.
- Lead hands-on CRF design and review, ensuring alignment with protocol objectives-, statistical analysis plans, and regulatory expectations.
- Develop, review, and approve data management plans (DMPs), database specifications, edit check specifications, data transfer agreements, and data review plans.
- Actively participate in EDC system configuration and validation activities, including review of database builds, user acceptance testing (UAT), and system change control.
- Perform ongoing hands-on data review, query trend analysis, and proactive data cleaning to ensure high-quality, analysis ready- datasets.
- Partner with Clinical Operations and other groups to define and implement data quality standards, reconciliation strategies, and risk based-monitoring approaches for clinical data.
- Lead hands-on-oversight of external CROs and vendors delivering data management services, including detailed review of deliverables, issue resolution, and escalation management.
- Ensure clinical trial data is compliant with applicable regulatory requirements, including GCP, ICH, and CDISC standards.
- Own and continuously improve clinical data management processes, tools, and SOPs to support efficient execution in a growing organization.
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