Merck KGaA Darmstadt Germany - Trenton, NJ
posted about 2 months ago
The Clinical Research Manager (CRM) - Immunology position at Merck is a remote role primarily responsible for the end-to-end performance and project management of assigned clinical trial protocols across various countries. This role requires compliance with ICH/GCP guidelines, country regulations, and Merck's internal policies and procedures. The CRM will serve as the main point of contact for assigned protocols, acting as a liaison between Country Operations and the Clinical Trial Team (CTT). The CRM is accountable for the performance of assigned studies, ensuring that all deliverables, timelines, and results meet the commitments made to the countries involved in the trials. In this role, the CRM will proactively plan, drive, and track the execution of studies from feasibility and site selection through recruitment, execution, and closeout. The CRM will review monitoring visit reports, escalate performance issues, and conduct quality control visits as necessary. Leading local study teams to achieve high performance is a key responsibility, which includes training local roles in the protocol and closely collaborating with Clinical Research Associates (CRAs) to ensure strong coordination across various local country roles. The CRM will also be responsible for creating and executing a local risk management plan for assigned studies, ensuring compliance with key systems such as CTMS and eTMF. The role involves 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 business relationships and represent Merck with investigators, supporting local and regional strategy development in alignment with long-term corporate needs. The CRM will also collaborate with various internal functions to align on key issues and decisions across trials, consulting with Global Health and Human Services (GHH) as needed.