Merck KGaA Darmstadt Germany - Boise, ID
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 clinical trials within a designated country. This position is designed to ensure that all assigned protocols are executed in strict compliance with International Council for Harmonisation (ICH) guidelines, Good Clinical Practice (GCP), and local regulations. 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, driving, and tracking the execution of deliverables, timelines, and results to meet country commitments from the feasibility stage through site selection, recruitment, execution, and study close-out. In addition to project management responsibilities, the aCRM will be accountable for the performance of assigned protocols, ensuring adherence to quality standards and adverse event reporting requirements both internally and externally. The role includes reviewing monitoring visit reports, escalating performance issues, and identifying training needs to the CRA-Manager and other relevant stakeholders. Quality control visits will also be performed as necessary to maintain high standards throughout the study lifecycle. The aCRM will lead local study teams, providing training on the protocol to other local roles and closely collaborating with Clinical Research Associates (CRAs) to ensure a strong team dynamic. This includes coordinating activities across various local roles, such as Clinical Trial Coordinators (CTCs) and Clinical Operations Managers (COMs). A critical aspect of this position is the development and execution of a local risk management plan for assigned studies, ensuring compliance with Clinical Trial Management Systems (CTMS), electronic Trial Master Files (eTMF), and other key systems. Furthermore, the aCRM will be responsible for fostering collaboration with functional outsourcing vendors, investigators, and other external partners involved in the studies. As a customer-facing role, the aCRM will build and maintain business relationships, representing Merck with investigators and supporting local and regional strategy development that aligns with long-term corporate objectives. This position requires a collaborative spirit, as the aCRM will work closely with various internal functions, including headquarters, regional operations, and clinical development teams.