Manager, Monitoring – Site Management

🕒 il y a 21 jours

🌲 North Carolina, Massachusetts, +3 états de plus – Distant

infoinfo

💵 €76 500 - €127 500 / an

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

👔 Manager

🗣️🇺🇸🇬🇧 Anglais requis

D'où vient cette offre

Publiée sur la page carrières de Alimentiv, pas via un site d'emploi

Repérée par Remote Rocketship il y a 21 jours

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Alimentiv

201 - 500 employés

Fondée en 2020

🏥 Santé

💼 Conseil

📦 Logistique

Healthcare • Consulting • Logistics

Alimentiv est une organisation de recherche sous contrat spécialisée dans les maladies gastro-intestinales (GI) et hépatiques. Avec plus de 30 ans d'expérience, Alimentiv offre une gamme complète de services de recherche clinique et d'imagerie, incluant la gestion d'essais cliniques, la gestion de sites, les affaires réglementaires et la médecine de précision. L'entreprise est à la pointe de la recherche et du développement médical, offrant des solutions d'imagerie de pointe et des analyses de biomarqueurs exploitables. Alimentiv soutient le développement de composés GI et est active dans plus de 60 pays, travaillant avec un réseau d'experts médicaux et opérationnels pour accélérer les essais cliniques et le recrutement de patients.

Description

• Plan, manage, organize, evaluate, and/or report on day-to-day delivery of the Clinical Monitoring unit • Develop and improve policies and processes • Monitor product quality, sites, and compliance • Plan staff resources and manage staff and contractor performance • Support, provide expertise to, and represent project and clinical monitoring teams with sponsors and researchers throughout the project life cycle • Ensure team members and third-party providers deliver high-quality, timely services in accordance with corporate and industry best practices and regulatory requirements • Identify, develop, plan, monitor, approve, and/or report on project-specific processes and services related to site selection, clinical monitoring, ICH-GCP compliance issue resolution, global project harmonization, SOP and QS document maintenance, periodic site visits, and IT collaboration • Represent and support Clinical Monitoring teams with internal partners and external sponsors to identify improvements, address concerns, and integrate new technologies and processes • Manage Clinical Monitoring team staffing, work allocation, resource planning, training and development, technology, process development, expense management, employee engagement, and performance management • Identify, procure, and manage Clinical Monitoring independent contractor services, including needs assessment, recruitment, contract negotiations, policy compliance, training, cost monitoring, and performance management • Develop tools supporting project teams and business development in clinical, site, and compliance monitoring from bidding through reporting findings to sponsors

🎯 Exigences

• College Diploma/University Degree in a relevant field (Health Sciences, Life Sciences preferred), or SoCRA and/or ACRP Certification/Designation • Minimum of 4–6 years of related experience plus substantial ongoing training • Experience managing CRA staff • Ability to provide training and/or mentorship to colleagues on a 1:1 basis or in meetings • Ability to work in a remote global capacity • Strong knowledge of regulations and guidelines pertaining to clinical monitoring and GCP • Customer service-oriented and solution-oriented approach • Demonstrated leadership skills • Strong verbal, written, and organizational skills • Ability to handle multiple tasks and meet deadlines in a dynamic environment

🏖️ Avantages

• Bonus • Home-based/remote work

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🗣️🇺🇸🇬🇧 Anglais requis

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