Study Start-Up Lead
2 weeks ago
We are seeking a highly skilled Study Start-Up Lead to join our team at Novartis Farmacéutica.
This is a hybrid office/home based position with 12 days per month to be performed from our White City office. The successful candidate will have very good knowledge of clinical trial design and mapping to supplier requirements.
The estimated salary for this role is around $110,000 - $160,000 depending on location and experience.
Key Responsibilities:
- 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
- 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)
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