Clinical Data Manager
San DiegoLast seen 14 days ago
Summary
The Clinical Data Manager will oversee data management activities for clinical trials, ensuring compliance with protocols, industry standards, and regulations. Responsibilities include managing Case Report Forms (CRF), Electronic Data Capture (EDC) systems, data review strategies, database lock coordination, and cross-functional collaboration with Clinical Operations, Biostatistics, CROs, and vendors. The role requires 2+ years of clinical data management experience, a bachelor's degree in a medical or scientific field, and proficiency with clinical data entry systems, CDISC standards, ICH guidelines, and FDA regulations.
Quality Assurance21 Cfr Part 11Case Report Forms CrfCdisc StandardsData Management Plans DmpData Transfer Agreements DtaElectronic Data Capture EdcElectronic Patient Reported Outcomes EproFda GuidelinesGxp Good Practice GuidelinesIch GuidelinesInteractive Response Technology IrtMicrosoft Office SuiteTrial Master File Tmf