Merck KGaA Darmstadt Germany - Boston, MA
posted 2 months ago
The Clinical Research Manager (CRM) for Immunology 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 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 trials from feasibility and site selection through recruitment, execution, and closeout phases. In this capacity, the CRM is accountable for the performance of assigned protocols, ensuring that all activities are conducted in accordance with regulatory requirements and company standards. Responsibilities include 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 other stakeholders. Additionally, the CRM is responsible for creating and executing local risk management plans and ensuring compliance with key systems such as CTMS and eTMF. The CRM also plays a significant role in building business relationships with investigators and external partners, representing the company in a customer-facing capacity. This position requires strategic thinking and collaboration with internal functions, regional operations, and global medical affairs to align on key issues and decisions across trials. The CRM must possess strong project management skills, a deep understanding of the clinical research landscape, and the ability to navigate complex regulatory environments effectively.