Clinical Trial Leader – FSP

🕒 3 dias atrás

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🟠 Sênior

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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 the set-up, execution, delivery, and closeout of assigned clinical trials • Provide leadership and direction to core and extended trial team members • Plan, implement, track, and oversee clinical trial activities and risk mitigation • Lead trial preparation, operational feasibility, recruitment planning, engagement plans, and patient-facing documents • Oversee country allocation, trial feasibility, vendor services, trial processes, budgets, quality monitoring, safety reporting, and regulatory/ethics responses • Maintain oversight of trial conduct, including GCP, regulatory requirements, SOP compliance, and continuous risk monitoring • Monitor patient recruitment and endpoint accrual and implement contingencies • Coordinate early clinical trial Innovation Unit tasks such as biomarker sampling, genomics, and sub-studies • Ensure timely clinical data cleaning, delivery, archiving in the TMF, and results/documents disclosure • Coordinate and support preparation of Clinical Trial Reports • Support trial strategy, milestone planning, operational and scientific input, and regulatory interactions • Communicate trial status to stakeholders and escalate issues as appropriate • Liaise with Clinical Trial Managers and internal and external stakeholders globally, across multiple countries or regions

🎯 Requisitos

• Strong clinical trial project management experience • In-depth project management understanding, emphasizing teamwork and high-performance teams • Oncology and/or inflammation experience • Understanding of major regulations including US FDA, EMA, and PMDA • Familiarity with guidelines and standard of care is desirable • Cross-geographical experience and understanding of multicultural and cross-cultural dynamics • Strengths in mentoring/coaching • Demonstrated agility, accountability, intrapreneurship, fast decision-making, flexibility, ownership, outcome-based thinking, results orientation, and smart risk-taking • Strong communication, active listening, and cultural awareness skills • Scientific and therapeutic knowledge and operational expertise across clinical trial planning and execution • Extensive international clinical trial project management experience • Leadership and influence capabilities in complex situations • Strategic, visionary, creative, courageous, and analytical mindset • Ability to set priorities, manage activity pace, and use resources efficiently • Effective project planning, prioritization, action definition, transparency, and clarity • University degree, such as a bachelor’s or advanced degree, with a major focus in Biomedical Life Sciences

🏖️ Benefícios

• Equal opportunity employer • Global, multicultural work environment • Opportunities for mentoring/coaching and professional development through leadership and team collaboration