Trial Vendor Associate Director

Hybrid

The location for this role is Dublin, Ireland. The working arrangement is Hybrid with an expectation of 12 days per month onsite. This position is also available in London, UK. Please apply to the specific Dublin requirement for this location. Novartis cannot support relocation for these positions. Please apply only if these locations are accessible to you. Novartis cannot sponsor Visas for these locations.

As a core member of the Clinical Trial Team (CTT), the main purpose of this position is accountability for vendor operational delivery at the study level to independently manage all clinical vendor related aspects of global clinical trial(s).

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 and work with the Vendor Start up Manager to ensure the protocol is appropriately represented in the vendor specifications.
• Oversee vendor financials, including budget tracking, invoice reconciliation, and PO management and close out.
• Collaborate with vendors, study start up leads and vendor start up managers to 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.