Senior Clinical Data Associate
Core
Provides 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 Clinical Data Associate
Builds
Clinical databases and data management documentation
Domain
Clinical research / Biopharmaceuticals
Required skills
Clinical trial data management, CRF specification development, database build UAT, edit check specification, medical coding (MedDRA/WHODrug), SAS programming basics, ICH-GCP compliance, vendor coordination
Preferred skills
Oncology therapeutic experience, Orphan Drug experience, CDISC standards knowledge (CDASH, SDTM, ADaM), clinical/scientific/healthcare discipline background
Technologies
EDC systems, Microsoft Office Suite, SAS
Responsibilities
Support Lead DM as backup/team member, perform data entry and quality control for paper-CRF studies, assist in building clinical databases, conduct database build UAT, review and query clinical trial data, perform line listing data review, run patient and study level status reporting, coordinate SAE/AE reconciliation, liaise with third-party vendors, assist with SAS programming QC, train clinical research personnel
Seniority
Senior, hands-on IC