Manager – Study Start Up

🕒 il y a 21 jours

🔔 Pennsylvania – Distant

🔔 Pennsylvania – Remote

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

👔 Manager

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ICON plc

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 1990

💊 Pharmaceutique

🧬 Biotechnologie

⚕️ Assurance santé

Pharmaceuticals • Biotechnology • Healthcare Insurance

ICON plc est un fournisseur mondial de services cliniques, de conseil et commerciaux à travers divers secteurs des industries de la santé et pharmaceutique. Ils offrent une vaste gamme de solutions cliniques, incluant des essais cliniques décentralisés, des solutions de sécurité cardiaque, des laboratoires cliniques précoces et de l'imagerie médicale. ICON fournit également des solutions technologiques qui soutiennent le développement de médicaments depuis les premières phases jusqu'à la post-commercialisation. Leur expertise thérapeutique couvre les domaines cardiovasculaire, oncologie, médecine interne et plus encore, avec un fort accent sur les thérapies transformatrices telles que les thérapies cellulaires et géniques ainsi que les biosimilaires. ICON est reconnu comme un leader dans le domaine de l'Organisation de Recherche Clinique (CRO), apportant régulièrement un leadership éclairé et contribuant à des publications et événements de l'industrie. Leurs services sont conçus pour optimiser les essais cliniques, offrir de l'intelligence réglementaire et fournir des preuves du monde réel à travers une analyse de données robuste et des solutions centrées sur le patient.

Description

• 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.

🎯 Exigences

• 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%)

🏖️ Avantages

• 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.