Associate Director managing Clinical Data Management at Summit Therapeutics, overseeing oncology clinical trial data management processes and staff. Ensuring data security and regulatory compliance throughout clinical studies.
Responsibilities
Lead the data management components of clinical trials
Manage data management staff, CROs, and service providers
Ensure clinical data security, integrity, and compliance
Develop and implement clinical data standards and management plans
Oversee database development, validation programming, and data review
Requirements
Bachelor’s degree in Life Sciences, Computer Science, or relevant field
Minimum of 10+ years of Clinical Data Management experience (oncology experience highly desirable)
Experience with various data collection and Electronic Data Capture (EDC) systems
Strong track record of line management and supervisory experience of CDM staff
Excellent interpersonal, communication, and leadership skills
Strong knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements
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