Novartis
Location
Secunderabad | India
Job description
• Close interaction and collaboration with study team lead and study team members during study lifetime, Review of vendor related protocol sections during protocol development. Collaborate with Vendor startup manager to the development of Study Specification Worksheet (SSW) to facilitate bid process. If no VSM is assigned to the category, drive the SSW completion. Manages interface with vendors in cooperation with vendor partner functions.
• Quote/proposal review in collaboration with procurement, support contract negotiations, if required Contributes to the development of vendor contract amendments, 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, Covers all vendor activities after study start-up and all categories not covered by VSMs during start-up.
• Initiates/co-ordinates vendor kick-off meeting for categories not covered by VSMs. Attends vendor kick-off meeting for VSM supported categories. Optimizing a frontloaded and timely study-start-up process, manages vendor-related activities for DB go live.
• Performs user-acceptance testing (UAT) for eCOA and IRT. Drives and monitors central vendor-related activities for site activation, compiles Final Protocol Package (FPP) required documents centrally, monitors site activation progress and addresses related issues and risk.
• Creates and maintains vendor-related risk maps with contingency plan for documentation in FIRST. Manages system and portal user access for vendor, sponsor and site staff, maintain access logs. Uses Unified Vendor Portal (UVP) to manage vendor.
• Uses Clinical Insights to manage vendors and to achieve site readiness timelines. Plans and tracks supply delivery to sites and return of equipment from sites. Interacts and collaborates with Data Ops, reviews vendor-related cycle times (e.g. DTS finalization, data transfers, DBL).
• Acts as escalation point for vendor-related query management. Follow-up with countries and hubs for their vendor-related risks and issues. Document issues identified with vendor oversight/performance in FIRST tool and implements and monitors corrective action.
• 8+ 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.
Job tags
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