Novartis
Salary Range:
£67,900.00 - £126,100.00
Job Description Summary
#Hybrid
The location for this role is Westworks, London, UK. The preferred working arrangement is Hybrid with an expectation of 12 days per month onsite, however this role can also be offered on a Remote working basis for people based in the UK only. Eligibility criteria apply and can be discussed at interview, if applicable.
This position is also available in Dublin, Ireland, on a Hybrid working basis only. 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).
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, People Management, Process Improvements, Project Planning, Vendor Management, Waterfall Model