Global Study Manager – FSP

🕒 6 dias atrás

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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

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• 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