Trial Vendor Associate Director

Key Responsibilities:

• Act as the single point of contact for vendor service delivery at the study level, partnering with vendors and cross-functional teams within the Clinical Trial Team (CTT)
• Provide end-to-end oversight of vendor deliverables, ensuring alignment with study timelines, scope, and quality expectations for vendors including (but not limited to) eCOA, central labs, IRT, cardiac, PR&R
• Review vendor-related protocol sections during protocol development. Work with the Vendor Start-up Manager to ensure that the protocol is appropriately represented in the vendor specifications
• Oversee vendor financials, including budget tracking, invoice reconciliation, and PO management and close-out
• In collaboration with vendors, study start up leads and vendor start up managers, ensure that all key vendor deliverables and documentation are in place to support submission during study start-up
• Lead UAT activities for vendor systems (e.g., eCOA, IRT), and contribute to vendor system validation
• Drive site activation from a vendor perspective, compile vendor related central documents, and address risks/issues during site activation and throughout the life-cycle of a site
• Manage vendor performance, risks, and issue resolution, driving mitigation plans in collaboration with vendors and study teams

Essential Requirements:

• Significant industry experience with clinical operations and vendor management processes (ideally 5+ years).
• Strong understanding of GxP and ICH regulations.
• Solid knowledge of clinical trial design and alignment to supplier requirements.
• Experience conducting User Acceptance Testing (UAT) for eCOA and IRT systems.
• Proven expertise in vendor management, including outsourcing, contracting, and sourcing clinical services.
• Results-oriented, with a track record of completing projects on time.
• Ability to collaborate effectively in cross-functional teams within a matrixed environment.
• Strong influencing, negotiation, communication, and problem-solving skills.

Preferable Requirements

• Audit & inspection experience
• Sponsor/CRO/vendor acquisition or transition studies experience
• Protocol writing experience