Merck KGaA Darmstadt Germany - Augusta, ME
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 protocols across various countries. This position ensures compliance with ICH/GCP guidelines, local regulations, and the company's internal policies and quality standards. 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 clinical studies from feasibility and site selection through to recruitment, execution, and closeout, ensuring that all deliverables and timelines are met effectively. In this role, the CRM will lead local study teams, providing training on protocols and collaborating closely with Clinical Research Associates (CRAs) and other local roles to ensure high performance and compliance. The CRM is also responsible for creating and executing local risk management plans, conducting quality control visits, and reviewing monitoring visit reports to identify and escalate any performance issues. The CRM will work with functional outsourcing vendors and investigators, managing relationships and ensuring that the studies are conducted in alignment with the company's strategic goals. The position requires strong project management skills, a deep understanding of the clinical research landscape, and the ability to navigate complex regulatory environments. The CRM must be adept at communicating effectively in a remote setting, managing resources, and driving project delivery while maintaining high standards of quality and compliance. This role also involves strategic thinking and the ability to identify and mitigate risks early in the process, ensuring that the clinical trials are executed smoothly and efficiently.