Manager, Clinical Data Management

Role Overview

The Manager of Clinical Data Management will lead clinical data management activities in support of CRISPR studies across all stages of clinical development. They will ensure that clinical data capture, systems and processes will ensure accurate, consistent, high quality, and complete data.

What You Will Do

Plan, coordinate, and manage data management tasks and timelines. Act as primary liaison with CROs, third party data vendors, and EDC vendors. Collaborate with internal clinical study team to ensure all stakeholders’ needs are addressed.

Why It Might Be a Fit

The successful candidate will impact multiple clinical development programs, health authority submissions, presentations and publications across internal and external stakeholders.

Requirements

• Bachelor’s degree in a health-related field
• Minimum of 7+ years of progressive experience in clinical data management in a regulatory environment
• Demonstrated proficiency managing the lifecycle of clinical data projects
• Experience developing reports using J-Review, Business Objects, or other CDM reporting tools
• Experience with EDC databases, especially Medidata Rave
• Experience with CDASH/SDTM/CDISC standards
• Experience working with central and specialty labs/vendors
• Working knowledge of medical terminology and medical coding dictionaries including MedDRA and WHO
• Familiarity with GCP, ICH and FDA requirements as applicable for Clinical Data Management

Benefits

• Base pay range of $123,000 to $133,000+ bonus
• Equity
• Benefits