Lead Data Manager
Madrigal Pharmaceuticals
June 27, 2026
Remote friendly (Conshohocken, PA)
United States
Clinical Research and Development
Lead Data Manager
Key Responsibilities:
- Serve as the Data Management lead for one or more clinical studies, accountable for end-to-end data management activities from study start-up through database lock.
- Develop and maintain study-level Data Management Plans (DMPs), CRF completion guidelines, edit check specifications, and other data management documentation.
- Lead EDC system setup, user acceptance testing (UAT), and database change control with vendors and internal teams.
- Coordinate and perform ongoing data review, query management, and data cleaning to ensure data integrity and completeness.
- Oversee external data handling (laboratory, ECG, imaging, PK/PD, and ePRO integrations), ensuring timely reconciliation and issue resolution.
- Monitor study progress, track data metrics, and proactively address data-related risks and delays.
- Lead database lock planning and execution, including review of data listings and coordination of cross-functional deliverables.
- Serve as primary point of contact for CROs, EDC vendors, and functional partners.
- Ensure compliance with SOPs, GCP, ICH, and regulatory requirements.
- Contribute to process improvement; may train/mentor junior staff.
Qualifications/Experience:
- Bachelor’s degree in Life Sciences, Computer Science, or related field.
- 5–7 years clinical data management experience in pharma/biotech, including study-level lead experience.
- Proficiency with EDC systems (Medidata Rave, Oracle InForm, or Veeva CDMS).
- Knowledge of CDASH, SDTM, and data integration practices.
- Working knowledge of ICH GCP and FDA/regulatory guidelines.
- Ability to manage vendor deliverables, timelines, and budgets.
- Strong organizational, analytical, problem-solving, and communication skills.
- Proficient in Microsoft Office (Excel, Word, PowerPoint, Outlook).
Preferred:
- Phase II/III global study data management leadership.
- Adaptive trial designs and complex data models.
- Experience with multiple external vendors and therapeutic areas (oncology/metabolic/cardiovascular).
- Regulatory inspection/sponsor audit experience; data review/visualization tools (JReview, Spotfire, SAS listings).
Key Responsibilities:
- Serve as the Data Management lead for one or more clinical studies, accountable for end-to-end data management activities from study start-up through database lock.
- Develop and maintain study-level Data Management Plans (DMPs), CRF completion guidelines, edit check specifications, and other data management documentation.
- Lead EDC system setup, user acceptance testing (UAT), and database change control with vendors and internal teams.
- Coordinate and perform ongoing data review, query management, and data cleaning to ensure data integrity and completeness.
- Oversee external data handling (laboratory, ECG, imaging, PK/PD, and ePRO integrations), ensuring timely reconciliation and issue resolution.
- Monitor study progress, track data metrics, and proactively address data-related risks and delays.
- Lead database lock planning and execution, including review of data listings and coordination of cross-functional deliverables.
- Serve as primary point of contact for CROs, EDC vendors, and functional partners.
- Ensure compliance with SOPs, GCP, ICH, and regulatory requirements.
- Contribute to process improvement; may train/mentor junior staff.
Qualifications/Experience:
- Bachelor’s degree in Life Sciences, Computer Science, or related field.
- 5–7 years clinical data management experience in pharma/biotech, including study-level lead experience.
- Proficiency with EDC systems (Medidata Rave, Oracle InForm, or Veeva CDMS).
- Knowledge of CDASH, SDTM, and data integration practices.
- Working knowledge of ICH GCP and FDA/regulatory guidelines.
- Ability to manage vendor deliverables, timelines, and budgets.
- Strong organizational, analytical, problem-solving, and communication skills.
- Proficient in Microsoft Office (Excel, Word, PowerPoint, Outlook).
Preferred:
- Phase II/III global study data management leadership.
- Adaptive trial designs and complex data models.
- Experience with multiple external vendors and therapeutic areas (oncology/metabolic/cardiovascular).
- Regulatory inspection/sponsor audit experience; data review/visualization tools (JReview, Spotfire, SAS listings).