Director Data Management
Core
Lead clinical data management (CDM) for prospective studies, clinical trials, external control arms, and registry cohorts, ensuring delivery of analysis-ready, submission-grade datasets.
Role type
Director, Clinical Data Management (hands-on leadership)
Builds
Study databases (EDC), CDISC-conformant deliverables (SDTM, ADaM), and analysis-ready datasets for life sciences sponsors
Domain
Life sciences / Clinical trials / Real-world evidence
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
EDC design and build, CDISC standards (CDASH, SDTM, ADaM), medical coding (MedDRA, WHODrug), regulatory compliance (ICH-GCP, 21 CFR Part 11), vendor management, team leadership
Preferred skills
SCDM certification (CCDM), real-world evidence/registry experience, Pinnacle 21, SAS, therapeutic area expertise (hepatology, dermatology, gastroenterology)
Technologies
Medidata Rave, Veeva Vault CDMS, Oracle Clinical/InForm, Pinnacle 21, SAS
Responsibilities
Design and validate EDC databases; author CRF guidelines aligned to CDISC; oversee medical coding and vendor management; ensure CDISC conformance for FDA/EMA submission; manage data quality, query resolution, and database lock; lead and mentor data management teams
Seniority
Director, hands-on leadership
