Clinical Trials Vendor Director
2 days ago
About the Role
As a key member of the Clinical Trial Team, you will be responsible for managing all clinical vendor-related aspects of global clinical trials. This includes independently leading the CTT vendor sub-team and working closely with the study lead and other team members throughout the duration of the study.
Key Responsibilities
Serve as an independent leader of the CTT vendor sub-team, translating vendor-related protocol sections into external service requirements.
Review and develop Study Specification Worksheets to aid the bid process, ensuring effective vendor cost control and budget review.
Support activities related to audits and inspections, including user acceptance testing for eCOA and IRT systems.
Collaborate with Site Activation teams to ensure successful site activation and data validation processes.
Develop and maintain relationships with key vendors, negotiating contracts and ensuring compliance with GxP and ICH regulations.
Essential Requirements
Prior experience in clinical operation processes and direct vendor management, including the sourcing and contracting of services.
Excellent knowledge of GxP and ICH regulations, with a strong understanding of clinical trial design and mapping to supplier requirements.
User Acceptance Testing (UAT) skills for eCOA and IRT systems.
Experience with site collaboration, site activation, and external data generation processes.
A good understanding of third-party data transfer specifications and reconciliation processes.
Desired Skills
- Budget Management
- Clinical Trials
- Negotiation Skills
- People Management
- Process Improvement
- Project Planning
- Vendor Management
- Waterfall Model
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