Senior Vendor Program Manager

Job Description Summary

The ideal location for this role is East Hanover where hybrid working principles apply. A distant working arrangement may be considered in certain states for US associates who are not within a daily commutable distance (more than 50 miles one way). Distant workers are responsible for the cost of home office expenses and periodic travel/lodging to East Hanover, as determined necessary by hiring manager.

About the role:
Core member of the Clinical Trial Team (CTT), independently managing all 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, escalates vendor issues to the VSM while keeping Vendor Program Leads informed about risks, issues, and study progress. Oversees vendor compliance at study level.

Your Key Responsibilities:
Accountable for all vendor related operational trial deliverables, 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 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

 

Job Description

Role Requirements:

• Bachelor's degree or equivalent degree is required, with advanced degree preferred.
• 3+ 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

The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining

to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity & Inclusion: The Novartis