Merck KGaA Darmstadt Germany - Trenton, NJ
posted about 2 months ago
The Associate Clinical Research Manager (aCRM) for Infectious Disease at Merck is a pivotal role that involves comprehensive project management and performance oversight for assigned clinical protocols within a specific country. This position is designed to ensure compliance with International Council for Harmonisation (ICH) guidelines, Good Clinical Practice (GCP), and local regulations, while also adhering to Merck's internal policies and quality standards. The aCRM will serve as the main point of contact for assigned protocols, acting as a crucial link between Country Operations and the Clinical Trial Team (CTT). This role requires a proactive approach to planning, executing, and tracking the performance of clinical studies from feasibility and site selection through to recruitment, execution, and closeout. In this role, the aCRM will be accountable for the overall performance of assigned protocols, ensuring that all activities are conducted in compliance with regulatory requirements and company standards. Responsibilities include reviewing monitoring visit reports, escalating performance issues, and conducting quality control visits as necessary. The aCRM will lead local study teams, providing training on protocols and ensuring strong collaboration among various local roles, including Clinical Research Associates (CRAs) and Clinical Trial Coordinators (CTCs). Additionally, the aCRM will be responsible for creating and executing local risk management plans and ensuring compliance with key systems such as the Clinical Trial Management System (CTMS) and electronic Trial Master File (eTMF). The position also involves collaboration with functional outsourcing vendors, investigators, and other external partners, as well as supporting local and regional strategy development in alignment with corporate needs. The aCRM will work closely with various internal functions, including Pharmacovigilance, Regulatory Affairs, and Global Medical Affairs, to ensure alignment on key issues and decisions across trials. This role is customer-facing, requiring the aCRM to build strong business relationships and represent Merck with investigators effectively. The position is remote, allowing for flexibility in work arrangements, but it does require up to 30% travel to meet the demands of the role.