Lead Data Manager
Madrigal Pharmaceuticals · Conshohocken -, PA
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Role summary
Madrigal Pharmaceuticals seeks a Lead Data Manager to oversee clinical data management activities for assigned studies, ensuring regulatory compliance and data quality throughout the trial lifecycle. The role requires coordinating cross-functional teams, managing EDC systems, and leading database delivery from study initiation through lock.
What they're looking for
- Bachelor's degree in Life Sciences, Computer Science, or related field
- 5–7 years clinical data management experience in pharma or biotech with lead-level responsibility
- Proficiency with EDC platforms such as Medidata Rave, Oracle InForm, or Veeva CDMS
- Strong knowledge of clinical data standards including CDASH and SDTM
- Working knowledge of ICH GCP, FDA, and regulatory guidelines for clinical research
- Demonstrated ability to manage vendor timelines, deliverables, and budgets
- Strong written and verbal communication skills with cross-functional presentation experience
What you'll be doing
- Lead end-to-end data management for one or more clinical studies from initiation through database lock
- Develop and maintain Data Management Plans, CRF guidelines, edit check specifications, and related documentation
- Oversee EDC system configuration, user acceptance testing, and database change controls with vendors
- Coordinate data review, query management, and cleaning to ensure data integrity and completeness
- Serve as primary contact for CROs, EDC vendors, and cross-functional partners on assigned trials
Privacy & handoff
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