Merck KGaA Darmstadt Germany - Springfield, IL
posted 2 months ago
The Clinical Research Manager (CRM) for Immunology at Merck is a pivotal role responsible for overseeing the end-to-end performance and project management of assigned clinical research protocols across multiple countries. This position ensures compliance with ICH/GCP guidelines, local regulations, and Merck's internal policies and procedures. The CRM serves as the main point of contact for assigned protocols, acting as a liaison between Country Operations and the Clinical Trial Team (CTT). This role requires proactive planning, execution, and tracking of study deliverables, timelines, and results to meet country commitments from feasibility and site selection through to recruitment, execution, and closeout. In addition to project management, the CRM is accountable for the performance of assigned protocols, ensuring adherence to quality standards and adverse event reporting requirements. The role involves reviewing monitoring visit reports, escalating performance issues, and conducting quality control visits as necessary. The CRM leads local study teams, providing training on protocols and ensuring strong collaboration among various local roles, including Clinical Research Associates (CRAs) and Country Operations Managers (COMs). Furthermore, the CRM is responsible for creating and executing local risk management plans and ensuring compliance with key systems such as CTMS and eTMF. As a customer-facing role, the CRM builds business relationships with investigators and external partners, supporting local and regional strategy development in alignment with long-term corporate needs. The position requires effective collaboration with various internal functions, including Global Medical Affairs and Pharmacovigilance, to address key issues and decisions across trials. The CRM must possess strong project management skills, a deep understanding of the local regulatory environment, and the ability to communicate effectively in a remote and virtual setting.