Global Study Manager – 6-month contract

🔥 0 minutes ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

🇬🇧 UK Skilled Worker Visa Sponsor

This company has sponsored UK Skilled Worker visas in the past.

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

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

• Lead and coordinate global clinical trial execution from sourcing strategy and study specification through study start-up, database release, inspection readiness, and study closure • Provide quality oversight and coordination of regional and country operations, Study Operational Managers, vendors, and pCROs • Lead operational teams in setting recruitment targets and delivery milestones • Serve as the operational sub-team representative on the core study team • Partner with the Clinical Study Team Lead to drive operational strategy and decision-making • Supervise and mentor Study Operational Managers and potentially other Global Study Managers • Develop, review, and approve study start-up, monitoring, recruitment, training, and other study-level plans • Oversee drug supply management and interactive randomization system setup • Manage vendor oversight, escalations, contracts, invoices, purchase orders, and budget spend • Review feasibility outputs, approve sites, and assess site activation plans • Ensure Trial Master File setup and study documentation compliance • Coordinate study and protocol training and global investigator meetings • Monitor study delivery, metrics, analytics, risks, and mitigation actions • Lead inspection readiness and site readiness activities • Interface with data management, clinical teams, CROs, pCROs, vendors, and site contracting groups • Review enrollment, discontinuations, protocol deviations, data reports, and dashboards • Provide operational input into protocol design and clinical trial budgets • Serve as a technical subject matter expert for study management systems and processes

🎯 Requirements

• Bachelor’s of Science or Bachelor’s of Arts degree with a minimum 7 years of relevant operational clinical trial experience required • Master’s of Science or Master’s of Business Administration degree with a minimum 6 years of relevant operational clinical trial experience required • Scientific or technical degree preferred • Extensive knowledge of clinical trial methodology • Experience in clinical research and/or study management • Study management/leadership experience • Experience with oversight of CROs and vendors • Experience managing per-subject costs, vendor and ancillary costs, monitoring cost projections, and spend • Exceptional knowledge of study management processes and deliverables • Working knowledge of Good Clinical Practices (GCPs), monitoring, clinical operations, and regulatory operations • Fluency in written and spoken English required • Ability to work outside core business hours as required to support global trials or initiatives • Ability to travel as required, including investigator meetings, vendor kick-off and re-set meetings, and client internal global or department-level meetings

🏖️ Benefits

• 6-month contract • Full-time employment • Ability to work remotely from the London, United Kingdom location • Opportunity to contribute to therapies that benefit patients and improve global health