Job Description Summary
We are seeking a highly experienced Clinical Trial Vendor Associate Director to join our team.
This role offers the opportunity to work closely with cross-functional teams and drive vendor management, budget control, and process improvements in global clinical trials.
Key Responsibilities
* Lead the Clinical Trial Team's vendor sub-team, collaborating with study leads and other team members throughout the study duration.
* Translate vendor-related protocol sections into external service requirements and review vendor specification documents.
* Develop Study Specification Worksheets to support bid processes, working closely with the Vendor Start-up Manager.
* Manage vendor cost control, budget review, invoice reconciliation, and PO close-out.
* Support activities related to audits and inspections.
Essential Requirements
* At least 5 years of experience in clinical operation processes and direct vendor management, including key clinical study vendors such as IRT, labs, eCOA, PRR, ECG, imaging.
* 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.
Skills Desired
* Budget Management
* Clinical Trials
* Negotiation Skills
* People Management
* Process Improvement
* Project Planning
* Vendor Management
* Waterfall Model