Senior Clinical Data Manager (Mexico)
Core
Lead data management for clinical trials from study start-up to database lock, ensuring data quality and regulatory compliance for drug/device/biologic development projects.
Role type
Senior Clinical Data Manager (Lead DM)
Builds
Clinical databases and data management documentation for pharmaceutical/biotech clients
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 process oversight, timeline management, vendor liaison, medical coding, SAS programming, SOP development, query resolution, line listing review, metric reporting
Preferred skills
Clinical/scientific/healthcare discipline experience, MedDRA and WHODrug coding, CDISC standards (CDASH, SDTM, ADaM), Oncology or Orphan Drug therapeutic experience
Technologies
EDC systems, Microsoft Office (Word, Excel, PowerPoint, Outlook), SAS
Responsibilities
Manage all aspects of clinical trial data management process; oversee project data entry process including guidelines and quality; develop CRF specifications from protocols; conduct database build UAT and maintain documentation; review and query clinical trial data; perform medical coding of medical terms; coordinate SAE/AE reconciliation; liaise with third-party vendors; assist with SAS programming and quality control; participate in SOP development; train clinical research personnel.
Seniority
Senior, hands-on IC with leadership responsibilities