Site Activation Leader

🕒 Setembro 21

🇺🇸 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 site activation planning and strategy development for assigned clinical studies, overseeing milestones and deliverables from site feasibility through last site activation • Develop, coordinate, and execute study critical path plans, including site feasibility, site selection, Regulatory Green Light, site initiation, site activation, system setup, Trial Master File and Expected Document List management, ethics committee and regulatory authority or Ministry of Health strategy, informed consent form customization, risk mitigation, activation requirements, tools, documents, and reporting • Monitor and report site activation progress across multiple studies, identify potential delays and risks, and lead cross-functional teams in resolving complex activation challenges • Provide guidance to site activation team members and serve as a liaison among project management, site start-up teams, site activation functions, and clinical operations leadership • Manage client relationships and communications regarding site activation timelines and deliverables, and serve as the Study Start-Up Subject Matter Expert for designated client accounts • Provide strategic guidance, best practice recommendations, and technical expertise to support study initiation and site activation outcomes • Support business development activities by contributing site activation expertise to proposals and bid pursuit meetings • Implement standardized site activation processes and best practices, analyze activation metrics, and drive process optimization and quality initiatives • Ensure compliance with regulatory requirements and company Standard Operating Procedures, and contribute to site activation procedures and templates • Lead use of Clinical Trial Management System, Electronic Data Capture, Interactive Response Technology, and Trial Master File systems to optimize site activation workflows • Oversee documentation, data integrity, system maintenance, timeline planning, and resource allocation across the assigned portfolio

🎯 Requisitos

• Bachelor's degree in Life Sciences, Healthcare, Business Administration, or a related field • 4-7 years of experience in clinical research operations with site activation leadership • Proven experience leading site activation teams and processes • Comprehensive knowledge of clinical trial start-up processes and requirements • Strong background in regulatory compliance in clinical research • Extensive experience working with clinical research sites and investigators • Demonstrated understanding of clinical trial timelines and milestone management • Excellent written and verbal communication skills with senior stakeholders • Strengths in site activation leadership, strategic planning, and cross-functional coordination • Comprehensive knowledge of clinical trial regulations, Good Clinical Practice, site activation processes, and clinical research operations • Advanced project management, critical thinking, problem-solving, and process improvement capabilities • Strong attention to detail and accuracy in complex clinical trial documentation

🏖️ Benefícios

• Health, Vision & Dental Insurance • Tuition Reimbursement • Vacation/Holiday/Sick Time • Flexible Spending & Health Savings Accounts • Work/Life Balance • 401(k) with Company match • Pet Insurance • Paid time off • Life insurance