ich-guidelines jobs in San Diego

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.…See more 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.

Lead clinical data management strategy, governance, and operations across a portfolio of clinical development programs in a biopharmaceutical environment. Manage CDM leaders and professionals, oversee data integrity initiatives, regulatory compliance, and vendor relationships while driving process improvements and technology modernization.…See more Requires 10–14+ years of clinical data management experience in pharma/biotech/CRO settings, with deep expertise in EDC platforms (Medidata Rave preferred), clinical data standards (CDASH, SDTM), GCP, ICH guidelines, and proven senior leadership capability.

The Clinical Data Manager will oversee clinical data management activities for assigned studies, ensuring compliance with protocols, industry standards, and FDA regulations. Responsibilities include managing CRO data management counterparts, developing and maintaining Electronic Data Capture (EDC), Interactive Response Technology (IRT), and Electronic Patient-Reported Outcomes (ePRO) systems, designing Case Report Forms (CRFs), establishing data review strategies, and coordinating data transfers.…See more The role requires collaboration across Clinical Operations, Clinical Safety, Biostatistics, and external vendors, with a focus on timely database lock and risk identification. Candidates need a bachelor's degree in a medical or scientific field, minimum 2 years of clinical data management experience, proficiency with Microsoft Office Suite, and knowledge of CDISC standards, ICH guidelines, 21 CFR Part 11, and FDA guidelines.