Senior Clinical Data Associate
Core
Senior Clinical Data Associate providing data management support and assistance in all aspects of the clinical trial data management process from study start-up to post database lock.
Role type
Senior IC clinical data manager
Builds
Clinical databases, CRF specifications, data management documentation
Domain
Clinical research / Life sciences
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Clinical trial data management, CRF development, database build and testing, data entry and quality control, medical coding (MedDRA/WHODrug), CDISC standards, ICH-GCP compliance, SAS programming basics, vendor liaison, project timeline management
Preferred skills
Clinical/scientific/healthcare discipline experience, Oncology or Orphan Drug therapeutic experience, Advanced SAS programming
Technologies
EDC systems, Microsoft Office, SAS, MedDRA, WHODrug, CDISC standards
Responsibilities
Support Lead DM as backup/team member, perform data entry and quality control for paper-CRF studies, assist in developing CRF specifications and building clinical databases, conduct database build UAT, specify requirements for edit checks, create and maintain data management documentation, train clinical research personnel, review and query clinical trial data, run patient and study level status reporting, perform medical coding, assist with SAE/AE reconciliation, liaise with third-party vendors, assist with SAS programming QC, identify and troubleshoot operational problems, assist in reviewing protocols/SAP/CSRs, participate in SOP development, communicate with sponsors and project teams.
Seniority
Senior, hands-on IC