摘要
Title: Trial Vendor Senior Manager.
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 Strategy Directors informed about risks, issues, and study progress. Oversees vendor compliance at study level.
#LI-Onsite
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
• 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
About the Role
Requirements:
- Bachelor 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
- Results-driven: demonstrated ability of completing projects on time
Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $114,000/yr and $211,900/yr; however, while salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
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The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
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