Associate Director of Clinical Operations
2 weeks ago
About the Job
Clinical Trial Vendor Associate Directors play a critical role in the success of our clinical trials. As a member of our team, you will be responsible for overseeing all clinical vendor-related aspects of global clinical trials, ensuring timely delivery of study outcomes within budget and quality standards.
Responsibilities
- Lead the clinical vendor team and collaborate closely with the study lead and other team members to ensure the successful execution of clinical trials.
- Develop and implement strategies for effective vendor management, including cost control, budget review, invoice reconciliation, and PO close-out.
- Work closely with the Vendor Start-up Manager to develop Study Specification Worksheets and ensure compliance with regulatory requirements.
- Support activities related to audits and inspections, site collaboration, and site activation.
Requirements
To succeed in this role, you will need:
- 5+ years of experience in clinical operation processes and direct vendor management, including key clinical study vendors like IRT, labs, eCOA, PRR, ECG, imaging.
- Experience in clinical trial design, mapping to supplier requirements, and sourcing and contracting services is required.
- Excellent knowledge of GxP and ICH regulations, as well as user acceptance testing for eCOA and IRT.
Skills and Qualifications
We are looking for candidates with excellent negotiation skills, people management skills, and a good understanding of external data generation and data validation processes.
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