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 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. We undertake vital clinical studies for sponsors including the leading global biotechs and Pharma top 50. And we have an incredible pipeline of work.
Expect exciting professional challenges in inspiring studies, but with time for your outside life.
Responsibilities
Operational Management / Deliverables:
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. 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.
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.
Activities & Interfaces:
Member of CTT; participant of CTT sub teams as needed. Manage all vendor-related activities for study lifetime.
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.
Here are a few requirements specific to this advertised role.
Education:
Bachelor's degree or equivalent degree is required, with advanced degree preferred.
Knowledge & Experience:
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).
Skills and experience:
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.
We care about our people and your passion, as they are the key to our success, and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term careers. In addition, you will have the opportunity to develop within your role and tackle further responsibilities or develop your skill set within other related departments of Parexel.
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.
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