Trial Vendor Senior Manager Job at Parexel

Job Description

Parexel is currently registering interest for Trial Vendor Senior Manager to join us in the UK, Ireland or France, dedicated to a single sponsor. As a core member of the Clinical Trial Team (CTT), this successful individual will independently manage all vendor-related aspects of global clinical trials to deliver study outcomes within schedule, budget, quality/compliance and performance standards. Proactively managing vendor-related risks and potential issues, this role will be accountable for all vendor-related operational trial deliverables. Working as a Trial Vendor Senior Manager at Parexel FSP offers tremendous long-term job security and prospects.

Job Responsibility

Interacts and collaborates closely with study team lead and study team members during study lifetime
Reviews vendor related protocol sections during protocol development
Collaborates with Vendor Study Manager (VSM) to the development of Study Specification Worksheet (SSW) to facilitate bid process
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
Manages 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 front loaded 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
Manages system and portal user access for vendors, sponsor and site staff, maintain access logs
Uses Unified Vendor Portal (UVP) to manage vendors
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 an 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
Member of CTT
participant of CTT sub teams as needed
Partners with Vendor Program Strategy Director organization to implement the defined program level vendor strategies successfully at both a program and trial level
Escalate risk and issues for selected categories to Trial Vendor Associate Directors Community Lead and/or Vendor Alliance Lead (VAL) as needed
Interacts and collaborates for vendor management with partner functions such as ESP QA and Procurement
Achieves excellence in vendor operations and management through process improvement in collaboration with the leadership and colleagues in other departments
Apply and encourage agile mindset, values, and principles
be an ambassador for agile and a catalyst for these new ways of working

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
Experience working with diverse cross-functional teams and a matrix environment and driving organizational excellence
Experience in User Acceptance testing for e-COA and IRT
Knowledge of key deliverables that impact green light milestones and vendor readiness
Experience or Expertise with Central Labs, Electronic Clinical Outcomes Assessment (eCOA), and Electronic Patient Reported Outcome (ePRO), Interactive Response Technology (IRT), Cardiac and Respiratory diagnostics, Patient Recruitment and Retention (PR&R), and/or Imaging reading (global process ownership, business system owner, SOP management, global training on supplier related SOPs and processes)
Very strong vendor management skills
outsourcing, contracting, and sourcing of clinical services
Results-driven: demonstrated ability of completing projects on time
Strong influencing and negotiation skills
Strong relationship building and good written and oral communication skills
Strong problem solving, negotiation, deadline driven and conflict resolution skills
Demonstrated willingness to make decisions and to take responsibility for such
Excellent interpersonal skills (team player)
Strong organizational awareness
advanced planning and project management skills
Proven networking skills and ability to share knowledge and experience amongst colleagues
Proficient in written and spoken English

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Trial Vendor Senior Manager

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