Job Description Summary
Are you ready to become a Clinical Trial Vendor Associate Director?
As a Clinical Trial Vendor Associate Director, you will be a core member of the Clinical Trial Team, independently managing all clinical vendor-related aspects of global clinical trials to deliver study outcomes within schedule, budget, quality/compliance, and performance standards.
Job Description
Key Responsibilities
Serve as the independent leader of the CTT vendor sub-team and a key member of the clinical trial team, working closely with the study lead and other team members throughout the duration of the study.
Review and translate vendor-related protocol sections into external service requirements and review vendor specification documents.
Work with Vendor Start-up Manager on developing the Study Specification Worksheet to aid the bid process.
Accountable for vendor cost control, budget review, invoice reconciliation, and PO close-out.
Support activities related to audits and inspections.
Essential requirements
5+ years of experience in clinical operation processes and direct vendor management. This includes direct management of key clinical study vendors, such as IRT, labs, eCOA, PRR, ECG, imaging. Additionally, experience in clinical trial design, mapping to supplier requirements, and the sourcing and contracting of these services is required.
Excellent knowledge of GxP and ICH regulations.
User Acceptance testing for eCOA and IRT.
Site collaboration and site activation.
Good understanding of external data generation and data validation processes (e.g., third party data transfer specifications, third party data reconciliation).
Skills Desired
Budget Management
Clinical Trials
Negotiation Skills
People Management
Process Improvement
Project Planning
Vendor Management
Waterfall Model
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