Merck KGaA Darmstadt Germany - Boise, ID
posted about 2 months ago
The Clinical Research Manager (CRM) for Immunology at Merck is a pivotal role that encompasses comprehensive project management and oversight for clinical trials across multiple countries. This position is primarily accountable for ensuring that all assigned protocols are executed in compliance with ICH/GCP guidelines, local regulations, and the company's internal policies and procedures. The CRM 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 eventual closeout of the studies. In addition to project management responsibilities, the CRM will be responsible for reviewing Monitoring Visit Reports, escalating performance issues, and identifying training needs for Clinical Research Associates (CRAs) and other team members. Quality control visits will also be part of the CRM's duties to ensure adherence to quality standards. The CRM will lead local study teams, providing training on protocols and fostering collaboration among various local roles, including CRAs and Clinical Trial Coordinators (CTCs). A critical aspect of this role is the development and execution of local risk management plans for assigned studies, ensuring compliance with Clinical Trial Management Systems (CTMS), electronic Trial Master Files (eTMF), and other essential systems. The CRM will also be responsible for identifying and sharing best practices across clinical trials and countries, collaborating with functional outsourcing vendors, investigators, and other external partners. As a customer-facing role, the CRM will build and maintain business relationships with investigators and may have the authority to sign contracts and manage budgets as needed, serving the local business needs of the company in their respective country.