COUNTRY OPERATIONS MANAGER
Primary point of contact to lead, manage and co-ordinate the conduct of clinical trials from study start-up to close out at a country level in accordance with ICH-GCP and other applicable local regulations. Maintain the quality and scientific integrity of clinical trials at a local/country level and actively collaborate with cross functional internal and external partners to ensure timely delivery, budget execution of clinical trial results within the local country.
Responsibilities:

• Partner with global and local country teams to provide high level country strategy and actively drive study progress and local/country level study delivery
• Planning, management and oversight of clinical study execution in accordance with the global program strategy, through leadership with engagement of the cross-functional Local Study Team
• Communicate country status (including timelines and deliverables) to key partners including updates to relevant systems for transparency
• Provides country level input into the Country Operational Plan and partners with the Development Feasibility Manager through feasibility and with the Global Clinical Managers to ensure local delivery of the study
• Support internal audit and inspection activities and contribute to CAPAs, including leading resolution of issues when appropriate e.g., vendor management

• Bachelor’s degree & 7+ years of directly related experience
• Advanced knowledge of global clinical trial management
• Fluency in local country language and English
• Experience in management and oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.)
• Ability to build strong site relationships as well as other local relationships to ensure end-to-end study delivery is met

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