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Clinical Vendor Manager - FSP - Remote

Key Facts

Remote From: 
Full time
Senior (5-10 years)
English

Other Skills

  • Accountability
  • Collaboration
  • Communication
  • Time Management
  • Teamwork
  • Empathy

Roles & Responsibilities

  • Minimum 5 years of working experience in clinical operations processes and vendor management
  • Excellent knowledge of GxP and ICH regulations
  • Very good knowledge of clinical trial design and mapping to supplier requirements
  • Experience with User Acceptance Testing for eCOA and IRT

Requirements:

  • Independently manage all vendor-related aspects of global clinical trials to deliver study outcomes within schedule, budget, quality/compliance, and performance standards with vendor service excellence at study level
  • Collaborate with study team and vendor partner functions; review vendor-related protocol sections during protocol development; coordinate vendor kick-off meetings and interface with vendors
  • Oversee vendor contracting processes including quotes/proposals, contract negotiations, amendments; manage cost control, budget reviews, invoice reconciliation, and PO close-out
  • Lead front-loaded study-start-up activities, vendor-related activities for database go-live, and perform user-acceptance testing (UAT) for eCOA and IRT

Job description

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Parexel are currently recruiting for an experienced Clinical Vendor Manager, to join one of our key sponsors in Europe. This is a fully remote opportunity.

In this role you will be accountable for 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.

Some specifics about this advertised role

  • Close interaction and collaboration with study team lead and study team members during study lifetime
  • Review of vendor related protocol sections during protocol development
  • 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 wider team during start-up
  • Initiates/co-ordinates vendor kick-off meeting for categories
  • Attends vendor kick-off meeting for 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

Who are Parexel

Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.

We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.

You’ll be an influential member of the wider team.

What we are looking for in this role

  • Minimum of 5 years of  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
  • User Acceptance testing for eCOA and IRT
  • Site collaboration and site activation
  • Vendor management; outsourcing, contracting, sourcing, of clinical services

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