Band
Level 5
Job Description Summary
#Hybrid
Job Description
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
Skills Desired
Budget Management, Clinical Trials, Negotiation Skills, People Management, Process Improvement, Project Planning, Vendor Management, Waterfall Model
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