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 • Oversee study management, site management, CRO, and vendor deliverables throughout the study lifecycle • Coordinate regional and country operations and CRO activities • Set recruitment targets, delivery milestones, study startup, monitoring, and study-level plans • Serve as a core team member and operational sub-team representative • Drive operational decision-making and partner with the Clinical Study Team Lead on strategy • Supervise and mentor Study Operational Managers and potentially other Global Study Managers • Develop, review, and approve startup, monitoring, recruitment, training, and other study plans • Oversee drug supply management and interactive randomization system setup • Manage vendor oversight, escalations, feasibility outputs, site approvals, and site activation plans • Ensure Trial Master File setup and contribute to risk planning • Coordinate study and protocol training and global investigator meetings • Provide clinical trial budget inputs and monitor vendor budgets, contracts, invoices, purchase orders, and spend • Resolve or triage site-level issues and lead inspection readiness and site readiness activities • Support decentralized capabilities at investigator sites • Ensure timely study closure and resource release • Review study metrics, analytics, data reports, and dashboards; mitigate risks and resolve issues • Interface with CRO feasibility, startup, monitoring, management, and site contracting groups • Coordinate with data management to ensure data flow and timely delivery • Assess enrollment and discontinuations for financial forecasting • Provide operational input into protocol design and lead protocol deviation trend reviews • Facilitate routine study management vendor calls • Serve as a technical expert for study management systems and processes • Champion harmonized processes and high-quality, timely clinical trial data deliverables • Provide technical oversight, continuous improvement, issue escalation and resolution, inspection readiness, quality assurance, performance feedback, and metrics review • Identify and resolve study operations staff performance issues • Support project-specific audits and inspections

🎯 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 one's function to ensure study goals are met • Expertise within the assigned therapeutic area and study • 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 • Scientific or technical degree preferred • Exceptional knowledge of own discipline and advanced knowledge of others • Ability to lead complex projects and develop innovative solutions to complex problems

🏖️ Benefits

• Global remote work arrangement • Opportunities to participate in global investigator meetings, vendor kick-off and re-set meetings, and client internal global or department-level meetings • Professional mentorship and supervision opportunities