Job Title: Senior Director of Clinical Data Management
Location: San Diego, CA
Compensation: $220K - $280K
About this Job:
The Senior Director of Clinical Data Management will be responsible for overseeing the data management activities of the clinical development team. This role will report directly to the Executive Director and will be responsible for mentoring and leading both full-time and contract employees, requiring a proven track record of leadership experience. Key responsibilities include working cross-functionally, and managing protocols within data collection, data processing, and data review. Additionally, the Senior Director will ensure compliance with regulatory requirements and industry standards, and will collaborate with other departments to optimize data management processes. The ideal candidate will possess strong analytical skills and the ability to drive continuous improvement initiatives within the team.
Job responsibilities:
- Lead and oversee data management and clinical programming activities for all company programs and studies, ensuring accountability and high performance.
- Manage all aspects of the Data Management and Clinical Programming teams, including resource planning, deliverables, staff training, appraisals, performance reviews, and salary reviews.
- Develop and enforce Data Management Departmental SOPs, ensuring adherence to company policies, federal guidelines, and GCPs.
- Forecast and manage the department budget for both external and internal expenditures.
- Collaborate with Quality and Clinical Compliance to ensure quality and continuous process improvement within clinical trial data management.
- Represent Data Management departments effectively at project review, quality review, and other stakeholder meetings.
- Guide data management activities for regulatory submissions and implement departmental changes to enhance productivity and strategy.
Basic Qualifications:
- Doctorate with a minimum of 10 years of data management experience, OR
- Master's degree with at least 10 years of data management experience, OR
- Bachelor's degree with a minimum of 12 years of data management experience
Preferred Qualifications:
- 16 years of clinical data management experience in the pharmaceutical industry
- 12 years of managerial experience in data management, including leading medium to large teams
- Expertise in clinical trial database construction, case report form design, and familiarity with CDISC and regulatory requirements
