Manager – Study Start Up

🕒 Maio 21

🔔 Pennsylvania – Remoto

🔔 Pennsylvania – Remote

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

👔 Gerente

Candidatar-se

Encontrar Vagas Remotas Similares

Receber Emails de Vagas Remotas

📊 Verifique sua pontuação de currículo para esta vaga

Melhore suas chances de conseguir uma entrevista verificando sua pontuação de currículo antes de se candidatar.

Enviar Currículo

ICON plc

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1990

💊 Farmacêutico

🧬 Biotecnologia

⚕️ Seguro de Saúde

Pharmaceuticals • Biotechnology • Healthcare Insurance

A ICON plc é uma provedora global de serviços clínicos, de consultoria e comerciais que atendem a diversos setores das indústrias de saúde e farmacêutica. A empresa oferece uma ampla gama de soluções clínicas, incluindo ensaios clínicos descentralizados, soluções de segurança cardíaca, laboratórios clínicos de fases iniciais e imagem médica. A ICON também fornece soluções de tecnologia que apoiam o desenvolvimento de medicamentos desde as fases iniciais até o pós-comercialização. Sua expertise terapêutica abrange cardiovascular, oncologia, medicina interna e mais, com forte foco em terapias transformadoras, como terapias celulares e gênicas e biossimilares. Reconhecida como uma das principais CROs (Contract Research Organisations), a ICON oferece regularmente thought leadership e contribui para publicações e eventos do setor. Seus serviços são personalizados para otimizar ensaios clínicos, fornecer inteligência regulatória e gerar evidências do mundo real por meio de análise de dados robusta e soluções centradas no paciente.

Descrição

• Manage day-to-day site start-up and activation activities, supporting your team to deliver quality outcomes. • Managing and overseeing the end-to-end study start-up process, including site identification, feasibility, regulatory submissions, and site activation. • Leading a team of study start-up professionals, providing guidance, mentorship, and support to ensure high performance and successful project delivery. • Collaborating with sponsors, clinical operations, and regulatory teams to ensure compliance with local and global regulations and timelines for clinical trial initiation. • Monitoring study start-up metrics, timelines, and budgets to ensure projects are delivered on time and within scope. • Identifying potential risks and challenges in the start-up process and implementing strategies to mitigate delays or issues. • Driving continuous improvement initiatives to optimize the study start-up process and enhance overall efficiency.

🎯 Requisitos

• Bachelor's degree in a relevant scientific discipline or healthcare-related field • Extensive experience in clinical trial study start-up, with a strong understanding of global regulatory requirements and clinical operations. • Proven leadership skills, with experience managing and mentoring teams in a fast-paced, deadline-driven environment. • Excellent organizational and project management skills, with the ability to handle multiple studies and priorities simultaneously. • Strong communication and stakeholder management skills, with the ability to collaborate effectively with sponsors and internal teams. • Experience with process optimization and implementing best practices in study start-up activities. • Willingness to travel as required (approximately 25%)

🏖️ Benefícios

• Various annual leave entitlements • A range of health insurance offerings to suit you and your family’s needs. • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being. • Life assurance • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.