Associate Director of Clinical Operations
7 days ago
Join our clinical trial team as an Associate Director of Clinical Operations and take on a key leadership role in managing all vendor-related aspects of global clinical trials.
Your Key Responsibilities:
- Independently manage all vendor-related aspects of global clinical trials, ensuring timely delivery and high-quality results.
- Collaborate with the study lead and other team members to develop and implement effective strategies for vendor management.
- Review and translate vendor-related protocol sections into external service requirements, ensuring seamless communication with vendors.
- Oversee vendor cost control, budget review, invoice reconciliation, and PO close-out, ensuring accurate financial management.
- Support activities related to audits and inspections, maintaining compliance with regulatory standards.
Requirements:
- 5+ years of experience in clinical operation processes and direct vendor management, including direct management of key clinical study vendors.
- Excellent knowledge of GxP and ICH regulations, ensuring compliance in all aspects of vendor management.
- User Acceptance testing for eCOA and IRT, ensuring high-quality deliverables.
- Site collaboration and site activation skills, driving successful project outcomes.
- Good understanding of external data generation and data validation processes, ensuring accurate data management.
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