Global Study Manager – FSP

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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 database release and inspection readiness • Provide operational oversight of regional and country operations, CROs, vendors, study management functions, and delegated Study Operational Managers • Set recruitment targets and delivery milestones and ensure delivery against approved study plans • Represent the operational sub-team on study execution matters and drive operational decision-making with the Clinical Study Team Lead • Develop, review, and approve study start-up, monitoring, recruitment, training, and other study-level plans • Oversee drug supply management, interactive randomization systems, vendor oversight, system setup, and study completion activities • Lead feasibility, site approval, site activation planning, Trial Master File setup, risk planning, investigator meetings, and protocol training • Provide input to clinical trial budgets and monitor vendor costs, contracts, invoices, purchase orders, forecasts, and spend • Resolve or triage site-level issues, lead inspection readiness and site readiness activities, and support decentralized capabilities at investigator sites • Review study metrics, analytics, data reports, and dashboards to identify risks and drive mitigation actions • Interface with CRO feasibility, study start-up, monitoring, management, and site contracting groups • Coordinate with data management and cross-functional colleagues to ensure data flow alignment and timely delivery • Assess enrollment and discontinuations for financial forecasting and provide operational input into protocol design • Lead protocol deviation trend reviews and facilitate routine study management vendor calls • Serve as a technical expert for study management systems and processes and champion harmonized, high-quality deliverables • Provide technical oversight, continuous improvement, issue escalation and resolution, inspection readiness, quality assurance, and performance feedback for the operational sub-team • Support project-specific audits and inspections and address study operations staff performance issues

🎯 Requirements

• Experience in clinical research and/or study management • Study management and leadership experience • Experience overseeing CROs and vendors • Experience managing per-subject costs, vendor and ancillary costs, monitoring cost projections, and spend • 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 • Exceptional knowledge of study management processes and deliverables • Knowledge of responsibilities beyond the candidate's own function to ensure study goals are met • Expertise within the assigned therapeutic area and study to set strategy, identify risks, and drive operational deliverables • Working knowledge of Good Clinical Practices (GCPs), monitoring, clinical operations, and regulatory operations • 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 • A scientific or technical degree is preferred • Exceptional knowledge of own discipline and advanced knowledge of others • Ability to develop ideas, lead complex projects, develop innovative solutions, exercise judgment, and act independently

🏖️ Benefits

• Ability to work remotely • Ability to travel, as required, including investigator meetings, vendor kick-off and re-set meetings, and client internal global or department level meetings