Expert Vendor Program Manager, Clinical Trial Operations - Novartis
East Hanover, NJ
About the Job
Core member of the Clinical Trial Team (CTT), independently handling all clinical vendor-related aspects of global clinical trial(s) to deliver study outcomes within schedule, budget, quality/compliance and performance standards. Accountable for vendor service delivery at study level. Collaborates closely with the Vendor Start-up Manager (VSM) for selected services (central labs, electronic clinical outcomes assessment/electronic patient reported outcomes (eCOA/ePRO), interactive response technology (IRT), cardiac and respiratory diagnostics, patient recruitment and retention (PR&R,) and imaging reading) during study start-up and leverages effectively their technical- and study start-up (SSU) expertise to ensure a timely study start-up. Proactively manages vendor-related risks and potential issues. Implements global vendor strategy and if required, raises vendor issues to the VSM or VCE while keeping Trial Lead and Vendor Program Leads informed about vendor risks and issues. Oversees vendor compliance at study level.
Accountabilities
Accountable for all clinical vendor related operational trial results, according to timelines, budget, operational procedures, quality/compliance and performance standards. Collaborates with the VSM for the VSM’s category specific responsibilities. Responsible for all activities for which no VSM is assigned with, and for all of the service deliveries after Study Start-up when the VSM is no longer assigned to the study.
Assigned responsibilities can include but are not limited to:
• Close interaction and collaboration with study Trial 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 collaborate 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
Accountabilities
Accountable for all clinical vendor related operational trial results, according to timelines, budget, operational procedures, quality/compliance and performance standards. Collaborates with the VSM for the VSM’s category specific responsibilities. Responsible for all activities for which no VSM is assigned with, and for all of the service deliveries after Study Start-up when the VSM is no longer assigned to the study.
Assigned responsibilities can include but are not limited to:
• Close interaction and collaboration with study Trial 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 collaborate 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
Source : Novartis