Senior Clinical Data Manager
Core
Lead data management for clinical trials from study start-up to database lock, ensuring data quality, timeline adherence, and regulatory compliance for life sciences therapies.
Role type
Senior Clinical Data Manager (Lead DM)
Builds
Clinical trial databases and data management deliverables for life sciences sponsors
Domain
Life Sciences / Clinical Research / Drug Development
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Clinical trial data management, database development and testing, CRF specification, data entry guidelines and training, quality control of data entry, timeline management, resource assessment, medical coding, SAE/AE reconciliation, vendor management, SAS programming, SOP development, stakeholder communication
Preferred skills
Clinical/scientific/healthcare discipline experience, MedDRA and WHODrug dictionary coding, CDISC standards (CDASH, SDTM, ADaM), Oncology or Orphan Drug therapeutic experience, Biostatistics knowledge
Technologies
Medidata Rave, Veeva, SAS
Responsibilities
Lead primary data management for assigned clinical projects, oversee data entry process and quality, develop CRF specifications and database build documentation, manage timelines and resource needs, coordinate SAE/AE reconciliation, liaise with third-party vendors, assist with SAS programming and quality control, participate in protocol and SAP reviews, develop and maintain SOPs, train clinical research personnel, run patient and study level status reporting
Seniority
Senior, hands-on IC with leadership responsibilities
