Senior Manager, Clinical Data Management

Generate Biomedicines seeks an experienced Senior Manager of Clinical Data Management to lead data management activities for clinical studies from initiation through database lock. The role combines strategic oversight with hands-on execution, including vendor management, database configuration, testing, and data quality assurance in a fast-paced biotech environment.

Responsibilities

• Lead data management strategy, timelines, and deliverables for assigned clinical studies and programs
• Oversee Medidata Rave EDC database builds including eCRFs, edit checks, and custom functions; create and interpret supporting reports
• Plan and execute database build testing, identify defects, assess impact, and verify resolutions through UAT
• Direct data review, query management, external data reconciliation, and database lock activities with vendor oversight
• Partner with cross-functional teams to communicate data management risks, decisions, and timelines; monitor data quality metrics and study timeline risks

Requirements

• Bachelor's degree in Life Sciences, Health Sciences, Computer Science, or related field; advanced degree preferred
• 7+ years of clinical data management experience in pharmaceutical, biotechnology, or CRO settings
• Hands-on expertise with Medidata Rave EDC, eCOA, and RTSM platforms
• Demonstrated experience creating, running, and interpreting Rave reports and listings
• Proven experience testing database builds, UAT scripts, edit checks, and eCRFs
• Strong knowledge of ICH-GCP guidelines and applicable regulatory requirements
• Proficiency in database design, data review, query management, and database lock processes