Manager, Clinical Data Manager Study Lead
Core
Oversees lead Data Managers for complex clinical studies, ensuring data management deliverables meet standards and timelines while acting as the primary point of contact for study teams and external partners.
Role type
Senior IC clinical data manager study lead
Builds
Clinical trial databases and data management deliverables for biopharmaceutical studies
Domain
Biotechnology / Pharmaceutical / Clinical Trials
Required skills
Clinical data management, eCRF design, database design, data quality review, MedDRA/WHO-DD coding, CRO oversight, SOP development, inspection readiness, risk mitigation
Preferred skills
None stated
Technologies
eCRF, Clinical trial database, MedDRA, WHO-DD
Responsibilities
Oversee DM activities from study start-up through archiving; Manage data transfers with CROs and third-party sources; Ensure design and maintenance of electronic case report forms and edit checks; Identify and resolve data quality and process execution gaps; Prepare recommendations for improved data management processes; Document sponsor oversight activities from protocol review to close-out.
Seniority
Manager, hands-on IC
