Clinical Operations Manager
hace 7 días
About Astellas:
Astellas is a progressive health partner committed to delivering value and outcomes where needed. We focus on innovative science, addressing areas of greatest potential and developing solutions for high-patient-need diseases. Our global vision for Patient Centricity supports the development of innovative health solutions through a deep understanding of the patient experience.
The Opportunity:
As a Clinical Operations Manager, you will be responsible for executing assigned tasks within the relevant Clinical Operations support function. This includes managing day-to-day operations, ensuring compliance with GCP/ICH guidelines, and providing accurate project status and financial information. You will guide Clinical Operations Compliance-related activities, including audit findings evaluation, CAPA execution, and process effectiveness checks. Additionally, you will be involved in Site Contracting activities, interacting with Site Budgets and Payments.
Key Responsibilities:
• Manage and lead day-to-day operations within relevant support functions to ensure completion per established goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
• Provide accurate and up-to-date project status and financial information (where appropriate) within relevant tracking systems/tools.
• Guide Clinical Operations Compliance-related activities inclusive of a holistic evaluation of CO-related audit findings, execution of CAPA and process-related effectiveness checks, and CO inspection readiness support.
• Site Contracting activities including interacting with Site Budgets and Payments.
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