Trial Vendor Startup Manager

🕒 2 days ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

Healthcare Insurance • Biotechnology • Pharmaceuticals

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Provide technical expertise for a given vendor category during study startup to the Vendor Program Manager (VPM) • Enable a flawless and accelerated vendor service delivery at the trial start-up phase • Proactively assess risk and conclude contingency plans to de-risk study startup • Interact closely with the Vendor Program Manager to achieve study objectives specifically for its assigned categories • Review vendor and category related specific sections of the protocol, ensure vendor expertise is leveraged when refining specifications towards Final Protocol • Contribute to development of Study Specification Worksheet (SSW) to facilitate bid process and selection of Vendors • Quote/Proposal review in collaboration with procurement (and vendor) • Support contract negotiations if required • Coordinate vendor kick-off meetings and other vendor specific meetings • Collect submission documents from vendor, as requested by countries participating in a study • Perform robust User Acceptance Testing (UAT) for eCOA and IRT • Ensure changes to protocol or study designs are consistently shared with vendors and incorporated into supplier budgets, timelines, and specifications • Support amendment of vendor contracts with Procurement team • Pro-actively create and maintain vendor related risk maps with contingency plans for documentation in FIRST • Document issues identified with vendor oversight / performance in FIRST tool and implement and monitor corrective actions • Escalate issue if required • Support the implementation of standards, templates, tools, and processes for vendors at SSU for defined categories • Support practice leaders in improvement projects and learning loops

🎯 Requirements

• Advanced degree in life sciences or business with equivalent direct clinical trial project management experience • Strong clinical project management experience including advanced level study start up work exposure with excellent knowledge of clinical operation processes and vendor management • Specific vendor category expertise – specifically such as Central Labs, eCOA/ePRO, IRT, Cardiac and Respiratory diagnostics, PR&R, Imaging reading • Hands on experience in User Acceptance testing (eCOA & IRT) specifically • Excellent knowledge of GxP and ICH regulations • Expert knowledge of clinical trial design and mapping to supplier requirements • Thorough and technical understanding of client specifications for supplier provided services • Demonstrated leadership with supplier relationship management and/or expert knowledge of specific service areas • Demonstrated partnering across divisions with internal and external stakeholders • Demonstrated root cause analysis, problem solving, and solution generation skills • Knowledge of key deliverables that impact green light milestones and vendor readiness • Experience in outsourcing, contracting, sourcing of clinical services with Vendor/CROs (RFP, RFQ, contracting)

🏖️ Benefits

• Competitive salary • Holiday • Pension