Merck KGaA Darmstadt Germany - Topeka, KS
posted about 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 trial protocols across multiple countries. This position requires a deep understanding of ICH/GCP guidelines, local regulations, and the company's policies to ensure compliance and quality standards are met throughout the clinical trial process. 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 is crucial in driving the execution of studies from feasibility and site selection through to recruitment, execution, and closeout, ensuring that all deliverables and timelines are met effectively. In addition to project management, the CRM is responsible for reviewing monitoring visit reports, escalating performance issues, and conducting quality control visits as necessary. The role involves leading local study teams, training team members on protocols, and ensuring strong collaboration among various local roles, including Clinical Research Associates (CRAs) and Country Operations Managers (COMs). The CRM also develops and executes local risk management plans, ensures compliance with key systems such as CTMS and eTMF, and identifies best practices across clinical trials. As a customer-facing role, the CRM builds and maintains business relationships with investigators and external partners, representing the company in a professional manner. The position also supports local and regional strategy development in alignment with long-term corporate goals, collaborating with various internal functions to address key issues and decisions across trials. The CRM must possess strong project management skills, a solid understanding of the local regulatory environment, and the ability to communicate effectively in a remote and virtual setting.