Senior Clinical Data Manager
Core
Lead Data Management contact responsible for overseeing the entire clinical trial data lifecycle from study startup to database lock, ensuring data quality, timeline adherence, and regulatory compliance.
Role type
Senior Clinical Data Manager (Lead DM)
Builds
Clinical databases and data management documentation for drug, device, and biologic development programs
Domain
Clinical Research / Life Sciences
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
Clinical trial data management, database development and testing, CRF specification, data entry guidelines, quality control, edit check specifications, medical coding (MedDRA/WHODrug), CDISC standards, SAS programming, vendor management, protocol/SAP/CSR review
Preferred skills
Oncology or Orphan Drug therapeutic experience, clinical/scientific/healthcare discipline background, bid defense and proposal development
Technologies
EDC systems, Microsoft Office, SAS
Responsibilities
Oversee project data entry process including guidelines development, training, and quality; Conduct database build UAT and maintain quality controlled documentation; Coordinate SAE/AE reconciliation; Liaise with third-party vendors; Train clinical research personnel; Review and query clinical trial data; Perform line listing data review; Run patient and study level status reporting; Participate in SOP development and maintenance
Seniority
Senior, hands-on IC with leadership responsibilities
