Global Study Manager – Project Leader

🔥 0 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

👷‍♀️ Project Manager

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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

• Provide operational leadership throughout the clinical study lifecycle • 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 • Coordinate regional and country operations and CRO activities • Set recruitment targets, delivery milestones, study startup, monitoring, and study-level plans • Lead the operational sub-team and represent it in the core study team • Drive operational decision-making and provide input into operational strategy and protocol design • 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, contracts, budgets, invoices, purchase orders, and cost variance • Coordinate country-level feasibility, site approval, site activation plans, Trial Master File setup, risk planning, protocol training, and investigator meetings • Resolve or triage site-level issues with cross-functional teams and CROs • Lead inspection readiness, site readiness, study closure, and resource release activities • Review study metrics, analytics, reports, and dashboards to identify risks and drive mitigations • Coordinate with data management to ensure data flow and timely delivery • Review protocol deviation trends and subject enrollment and discontinuation forecasts • Facilitate study management vendor calls • Serve as a technical expert for study management systems and processes • Champion harmonized processes, continuous improvement, quality assurance, and excellence in study management deliverables • Support audits and inspections as a study management resource

🎯 Requirements

• 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 • 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 • Good knowledge of responsibilities beyond one's function to ensure study goals are met • Expertise in 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 • Scientific or technical degree preferred • Exceptional knowledge of own discipline and advanced knowledge of others • Ability to develop ideas and lead complex projects • Ability to develop innovative solutions to complex problems • Ability to exercise independent judgment and act independently

🏖️ Benefits

• Equal opportunity employer • Remote work arrangement indicated by the employer-selected location: United States-North Carolina-Remote