-Responsible for 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 assigned protocols in a country in compliance with ICH/GCP and country regulations, sponsor 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: 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
-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
-Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies
-Serves local business needs as applicable in his/her country(If delegated can sign contracts and manage budgets)
-Collaborates internally with HQ functions and locally with PV, Regulatory and GMA to align on key decisions in his/her studies. GHH to be consulted as needed.
-As a customer-facing role, this position will build business relationships and represent company with investigators
-Shares protocol-specific information and best practices across countries/clusters
Bachelor above degree, major in life science field.
8+ years working experience in clinical trail field.
Global trial experience with therapeutic area in oncology.
+886 2 2757 7268 Ext 127
Rm. 1209, 12F., No.333, Sec. 1, Keelung Rd., Xinyi Dist., Taipei City 110, Taiwan