Global Study Manager – Project Leader

🕒 Agosto 27

🌲 North Carolina – Remoto

🌲 North Carolina – Remote

⏰ Tempo Integral

🟠 Sênior

👷‍♀️ Gerente de Projetos

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Parexel

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1983

💼 Consultoria

🏥 Saúde

📦 Logística

💰 Venture Round em 1990-01

Consulting • Healthcare • Logistics

Parexel é uma das maiores organizações de pesquisa clínica (CROs) do mundo, oferecendo serviços abrangentes para o processo de desenvolvimento clínico das Fases I a IV. A empresa é especializada em gestão de portfólio, gestão de ensaios clínicos, estratégia regulatória, acesso ao mercado e gestão do ciclo de vida para biofarmacêuticos. A Parexel busca acelerar a chegada de medicamentos que transformam vidas ao mercado, alavancando sua expertise clínica, regulatória e terapêutica. Com uma equipe global de mais de 21. 000 profissionais, a Parexel trabalha para integrar insights de pacientes e desenhos de estudo inovadores a fim de desenvolver tratamentos em áreas terapêuticas como oncologia, neurociência, doenças raras, entre outras. Seu foco está na condução de ensaios clínicos eficientes e centrados no paciente.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

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