Merck & Co. - Rahway, NJ
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 protocols across multiple countries. This position ensures compliance with ICH/GCP guidelines, local regulations, and the company'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). The role requires proactive planning, execution, and tracking of study deliverables, timelines, and results to meet country commitments from feasibility through to site selection, recruitment, execution, and closeout. In this role, the CRM is accountable for the performance of assigned protocols, ensuring adherence to quality standards and adverse event reporting requirements. 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 collaborating closely with Clinical Research Associates (CRAs) to ensure strong coordination across various local roles. 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 crucial role in building business relationships with investigators and external partners, serving as the country point of contact for programmatically outsourced trials. This position supports local and regional strategy development in alignment with long-term corporate needs and collaborates with various internal functions to address key issues and decisions across trials. The role requires strong project management skills, a deep understanding of the local regulatory environment, and the ability to communicate effectively in a remote and virtual setting.