fda-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.

Principal Specialist overseeing clinical data management for pharmaceutical studies, responsible for database lock coordination, CRO performance monitoring, and ensuring quality control and audit procedures meet departmental standards. The role requires running data review listings, coding medical history and adverse event data using MedDRA, coding concomitant medications using WHO Drug dictionaries, and collaborating with database programmers to ensure CDISC/SDTM compliance.…See more Requires 8+ years of pharma industry experience (or equivalent with advanced degree), strong knowledge of Good Clinical Data Management Practices, and demonstrated ability to lead and manage teams across multiple projects.

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.