Job Description

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, 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 us 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 in conjunction with CRD, TAH and Regional Operations. Collaborates internally with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilance, Global Medical Affairs to align on key issues/decisions across the trials. Consult with GHH as needed. Experience Requirements: Required: 5-6 years of experience in clinical research CRA Experience preferred Educational Requirements: Bachelor degree in Science (or comparable) is required Advanced degree, (e.g., Master degree, MD, PhD) is preferred

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