at Merck in Boise, Idaho, United States Job Description Job Description This role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH / GCP and country regulations, our Company policies and procedures, quality standards and adverse event reporting requirements internally and externally. The CRM could be responsible for a particular study for several countries in a cluster. Responsibilities include, but are not limited to: + Main Point of Contact ( POC ) for assigned protocols and link between Country Operations and clinical trial team ( CTT ). + Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out. + Accountable for performance for assigned protocols in a country in compliance with ICH / GCP and country regulations, our Company policies and procedures, quality standards and adverse event reporting requirements internally and externally. + Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed. + Performs Quality control visits as required. + Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration (including the CTC , CRAs and COM ). + Responsible for creating and executing a local risk management plan for assigned studies. + Ensures compliance with CTMS , eTMF and other key systems in assigned studies. + Escalates as needed different challenges and issues to TA Head/ CRD / CCQM and or CTT (as appropriate). + Identifies and shares best practices across clinical trials, countries, clusters. + Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies. + Country POC for programmatically outsourced trials for assigned protocols. + As a customer-facing role, this position will build business relationships and represent our Company with investigators. + Serves local business needs as applicable in his/her country (if delegated can sign contracts and manage budgets). + Supports local and regional strategy development consistent with long-term corporate needs i To view full details and how to apply, please login or create a Job Seeker account