Global Study Manager II

🕒 Agosto 5

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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 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

🎯 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 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