We are currently seeking a Trial Vendor Associate Director to be based in Dublin, Ireland. This is a hybrid office/home based position with 12 days per month to be performed from the office.
As a core member of the Clinical Trial Team (CTT), the main purpose of this position is accountability for vendor service delivery at the study level to independently manage all clinical vendor related aspects of global clinical trial(s).
About the Role
* Close interaction and collaboration with study team lead and study team members during study lifetime
* Review of vendor related protocol sections during protocol development
* Manage interface with vendors in cooperation with vendor partner functions
* Quote/proposal review in collaboration with procurement, support contract negotiations, if required
* Contribute to the development of vendor contract amendments and accountable for vendor cost control, budget review, invoice reconciliation and PO close-out
* Vendor service excellence at study level, ensures vendors meet quality and service level standards in their service delivery for the trial
* Cover all vendor activities after study start-up and all categories not covered by VSMs during start-up
* Initiate/co-ordinate vendor kick-off meeting for categories not covered by VSMs
* Attend vendor kick-off meeting for VSM supported categories
* Optimizing a frontloaded and timely study-start-up process, manage vendor-related activities for DB go live
* Perform user-acceptance testing (UAT) for eCOA and IRT
* Drive and monitor central vendor-related activities for site activation, compile Final Protocol Package (FPP) required documents centrally, monitor site activation progress and address related issues and risk
* Creates and maintains vendor-related risk maps with contingency plan for documentation in FIRST
* Interact and collaborate with Data Ops, reviews vendor-related cycle times (e.g. DTS finalization, data transfers, DBL)
Key Responsibilities:
* 5+ years working experience and excellent knowledge of the clinical operation processes and vendor management
* Excellent knowledge of GxP and ICH regulations
* Very good knowledge of clinical trial design and mapping to supplier requirements
* Thorough and technical understanding of Novartis specifications for supplier provided services
* User Acceptance testing for eCOA and IRT
* Site collaboration and site activation
* Vendor management; outsourcing, contracting, sourcing, of clinical services
* Results-driven: demonstrated ability of completing projects on time
* Ability to work in cross-functional teams and a matrixed environment
* Strong influencing and negotiation skills
* Good written and oral communications skills
* Very good problem-solving skills
* Demonstrated willingness to make decisions and to take responsibility for such
* Excellent interpersonal skills (team player)
* Proven networking skills and ability to share knowledge and experience amongst colleagues
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