Senior Manager, Study Start-up

🕒 Junho 11

🇺🇸 Estados Unidos – Remoto (EUA)

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Parexel

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1983

⚕️ Seguro de Saúde

🧬 Biotecnologia

💊 Farmacêutico

💰 Venture Round em 1990-01

Healthcare Insurance • Biotechnology • Pharmaceuticals

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

• Responsible for driving global study start-up and site activation activities, milestone oversight, and CRO delivery. • Develop and deliver the global study startup plan by partnering with the CRO Study Startup team. • Lead development of procedures to enhance internal start-up capabilities and drive efficiencies to align with Trial Delivery Optimization goals. • Guide study teams through conduct and delivery of key startup activities within timelines that contribute to operational planning/decisions resulting in predictable delivery for achieving R&D goals. • Oversee the analysis of clinical trial data and its application to conduct accurate study startup forecasts. • Collaborate with internal Feasibility experts to drive rapid, accurate, and data-driven study startup forecasts, benchmarking assumptions, scenarios and accurate planning. • Develop creative processes, methodologies, data and technologies to ensure ongoing delivery of valued Study Startup Services. • Participate in early, global, strategic study planning to ensure corporate goals and timelines for study start-up and site activation are accurate and achievable; ensure CRO commitment to all study deliverables and timelines. • Partner with CRO to ensure efficient start-up processes and reporting to deliver best in practice country and site activations. • Work directly with internal study team members and CRO counterparts to progress site activations efficiently and as per targeted milestones; facilitates timely resolution of site-level issues by utilizing in-country intel and expertise to remove or prevent roadblocks. • Tracks and reports relevant KPIs and metrics including local country and site level cycle times to support process improvement and overall operational/business reporting to accelerate site activation. • Oversee consistent application of appropriate study start-up standards and processes to deliver high quality, cost effective clinical studies in line with local operational, legal and regulatory requirements. • Build and maintain study start-up, country and site activation best practices. • Support the recruitment and performance of junior staff; provide guidance for effective prioritization, problem identification and solving resulting in improved strategic drug development operational efficiency.

🎯 Requisitos

• Bachelor’s Degree in Science or related discipline required. • Significant (8+ years) previous experience gained with a CRO or biopharmaceutical company working on multinational clinical studies. • Considerable (5+ years) managing operational aspects of clinical studies. • Significant experience in leading global study start-up and site activation activities is required. • Must have experience working with external CROs and cross functional teams. • Broad-based experience in clinical development including clinical trial conduct, Study Start-up and feasibility, country and site selection and patient retention and recruitment. • Knowledge of GCP and a good understanding of the processes associated with clinical operations, study management and monitoring, and local regulatory requirements.

🏖️ Benefícios

• Health insurance • Retirement plans • Paid time off • Flexible work arrangements • Professional development