Merck & Co. - Rahway, NJ
posted 2 months ago
In this role, you will be accountable for the end-to-end performance and project management for assigned clinical trial protocols within a specific country. This includes ensuring compliance with ICH/GCP guidelines, country regulations, and our company's policies and procedures. You will serve as the main point of contact for assigned protocols, acting as a vital link between Country Operations and the Clinical Trial Team (CTT). Your responsibilities will encompass proactive planning, driving, and tracking the execution and performance of deliverables, timelines, and results to meet country commitments from feasibility and site selection through to recruitment, execution, and closeout of studies. You will be responsible for reviewing Monitoring Visit Reports, escalating performance issues, and identifying training needs to the CRA-Manager and/or functional vendors. Additionally, you will perform quality control visits as required and lead local study teams to achieve high performance. This includes training local roles in the protocol, collaborating closely with Clinical Research Associates (CRAs), and coordinating activities across various local country roles to ensure strong collaboration. Your role will also involve creating and executing 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. You will escalate challenges and issues to the TA-Head, CRD, CCQM, or CTT as appropriate, and share best practices within the team. As a customer-facing role, you will build business relationships and represent our company with investigators, supporting local and regional strategy development in alignment with long-term corporate needs. Collaboration with internal functions such as EU Clinical Development, Pharmacovigilance, Regulatory Affairs, and Global Medical and Scientific Affairs will be essential to align on key issues and decisions across trials. You will also be expected to consult with Human Health as needed. This position requires travel of up to 30% of your working time, and you will need to demonstrate strong project management skills, organizational abilities, and a deep understanding of the local regulatory environment.