Merck KGaA Darmstadt Germany - Dover, DE
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 research protocols. This position is primarily remote and requires compliance with ICH/GCP guidelines, country regulations, and the company's internal policies and procedures. The CRM will serve 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 ensuring that clinical trials are executed efficiently and effectively, meeting all commitments from feasibility and site selection through to recruitment, execution, and closeout. In this role, the CRM will be accountable for the performance of assigned protocols within a specific country, ensuring adherence to quality standards and adverse event reporting requirements. Responsibilities include reviewing monitoring visit reports, performing quality control visits, and leading local study teams to achieve high performance. The CRM will also be responsible for creating and executing local risk management plans, ensuring compliance with key systems such as CTMS and eTMF, and escalating challenges to the appropriate stakeholders as needed. The CRM will collaborate with functional outsourcing vendors, investigators, and other external partners, serving as the country point of contact for programmatically outsourced trials. This position requires strong project management skills, the ability to communicate effectively in a remote environment, and a deep understanding of the local regulatory landscape. The CRM will also support local and regional strategy development in alignment with long-term corporate needs, working closely with various internal functions to ensure alignment on key issues and decisions across trials.