Merck KGaA Darmstadt Germany - Oklahoma City, OK
posted about 2 months ago
The Clinical Research Manager (CRM) for Immunology at Merck is a pivotal role responsible for overseeing the end-to-end performance and project management of assigned clinical trial protocols across multiple countries. This position requires a deep understanding of ICH/GCP guidelines, local regulations, and the company's policies to ensure compliance and quality standards are met throughout the clinical trial process. 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). This role is crucial in driving the execution of studies from feasibility and site selection through recruitment, execution, and closeout, ensuring that all deliverables and timelines are met effectively. In this role, the CRM will lead local study teams, providing training on protocols and collaborating closely with Clinical Research Associates (CRAs) and other local roles to foster a high-performance environment. The CRM is also responsible for creating and executing local risk management plans, ensuring compliance with key systems such as CTMS and eTMF, and identifying best practices across clinical trials. This position requires strong project management skills, the ability to communicate effectively in a remote environment, and a strategic mindset to support local and regional strategy development in alignment with corporate needs. The CRM will also engage with external partners, including functional outsourcing vendors and investigators, to build strong business relationships and represent the company effectively. This role demands a proactive approach to problem-solving, negotiation skills, and the ability to manage conflicts and challenges that may arise during the clinical trial process. The CRM will be expected to travel up to 30% of the time, reflecting the need for in-person engagement with stakeholders and site visits as necessary.