Global Study Manager II

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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 startup, database release, and inspection readiness • Provide quality oversight and coordinate regional and country operations, Study Operational Managers, preferred CRO, and vendors • Set recruitment targets and delivery milestones and ensure execution against approved plans • Represent the operational sub-team on study execution matters and drive operational decision-making with the Clinical Study Team Lead • Supervise and mentor Study Operational Managers and potentially other Global Study Managers • Develop, review, and approve study startup, monitoring, recruitment, training, and other study-level plans • Oversee drug supply management and interactive randomization system setup • Manage vendor oversight, escalations, contracts, budgets, invoices, purchase orders, and spend forecasts • Review feasibility and pre-trial assessment outputs, approve sites, and assess site activation plans • Ensure Trial Master File setup and applicable system closure • Lead operational sub-team formation, resource requests, risk planning, protocol training, and global investigator meetings • Resolve or triage site-level issues with cross-functional teams and the preferred CRO • Lead inspection readiness and site readiness activities • Review study metrics, analytics, data reports, and dashboards; mitigate risks and resolve issues • Lead study startup and monitoring interfaces with CRO feasibility, startup, monitoring, management, and contracting groups • Provide operational input into protocol design and lead protocol deviation trend reviews • Serve as technical expert for study management systems and processes and champion harmonized processes and continuous improvement • Support audits, inspections, quality assurance, issue escalation, and performance feedback

🎯 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 for investigator meetings, vendor meetings, and global or departmental meetings • Exceptional knowledge of study management processes and 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 • Alternatively, 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 • Knowledge of clinical trial methodology • Ability to develop innovative solutions and lead complex projects • Ability to exercise independent judgment and act independently on self-initiated projects