Manager, Clinical Data Management

Role: Lead Clinical Data Manager supporting Immunocore's global clinical trials within the Clinical Operations department. Objectives include overseeing outsourced and in-house Data Management activities across phases 1-4, ensuring high-quality data collection, integrity, and compliance. Responsibilities encompass vendor management, study build and review, data extraction and analysis, process development, and oversight of TMF and database activities. The role involves collaboration with CROs, study teams, statisticians, and regulatory bodies, with a focus on oncology-related trials, particularly Phase III and pivotal studies. Qualifications: BA/BS in a scientific or healthcare field; minimum 5 years of experience in pharmaceutical/biotech data management or CRO, with proven project management skills. Must have strong knowledge of ICH/FDA guidelines, CDISC standards, 21 CFR 11, and experience with EDC systems like Medidata RAVE is preferred. Oncology experience is advantageous. The position requires independent work capability, attention to detail, and ability to manage multiple tasks. Work setup is on-site in Radnor, PA, with responsibilities for study oversight, vendor interactions, and data quality assurance.