Similar Jobs
See allManager, Clinical Data Management
Oruka Therapeutics
US
Clinical Data Management
EDC Systems
GCP/ICH Guidelines
Senior Clinical Data Manager
Precision Medicine Group
Europe
Clinical Data Management
EDC Systems
Medical Coding
Associate Data Manager - FS
Premier Research
Global
Clinical Data Management
EDC
Microsoft Office
Senior Principal Technical Data Specialist (LATAM)
Precision Medicine Group
Latin America
Clinical Data Management
EDC Systems
Data Governance
About the Role:
- Lead the strategy, build-out, and execution of clinical data management across the portfolio.
- Own data management planning, EDC systems, data standards, database lock, and CRO/vendor oversight.
- Ensure clinical database withstands Regulatory Authority scrutiny, including pre-approval inspection.
Key Responsibilities:
- Develop and execute clinical data management strategy aligned with regulatory timeline and submission milestones.
- Oversee development of Data Management Plans, CRF/eCRF design, and data validation plans.
- Manage relationships with data management CROs, EDC vendors, and specialty data vendors, including scope and budget.
Qualifications:
- Advanced degree in life sciences, health informatics, statistics, or related field; 12+ years of progressive clinical data management experience.
- Direct experience leading data management through at least one successful NDA, BLA, or MAA submission.
- Deep working knowledge of CDISC standards and hands-on experience with major EDC/CDMS platforms.
Prilenia
Prilenia is a private biopharmaceutical company focused on bringing transformative medicines to people with neurodegenerative diseases such as ALS and Huntington’s disease. They are a small to mid-size clinical-stage organization with a highly committed global team and a flexible, mostly remote culture.