Clinical Data Management

Bachelor's degree in Computer Science, Life Sciences, or related field 4+ years hands-on experience in IVD, Medical Device, or Pharmaceutical clinical data management Knowledge of GCP and GCDMP Proficiency in R, SAS Proficiency in SQL, PL/SQL Experience with EDC systems and clinical data management platforms (e.g. Medidata, Medrio) Experience with CTMS and eTMF platforms, strong preference for Veeva Vault Experience with sample management platforms (e.g. LabVantage) Familiarity with CDISC/CDASH/SDTM/ADAM standards Familiarity with FDA guidelines and regulations Experience with database validation and quality control processes Experience with clinical trials Experience with Medidata Experience with Veeva Vault Experience with LabVantage Understanding of clinical trial data workflows

Support end-to-end clinical data management operations Support implementation of data management plans and validation specifications Participate in design and validation of eCRF systems and edit checks Support database development, validation programming, and query management Collaborate with Clinical Affairs, Data Analysis, and IT teams Generate key metrics reports and data analytics