Senior Clinical Research Associate

🕒 il y a 1 mois

🌐 Pays-Bas, Belgique – Distant

🇳🇱 Pays-Bas – Télétravail 🇧🇪 Belgique – Télétravail

💵 €65 000 - €80 000 / an

⏰ Temps Plein

🟠 Senior

🧪 Chercheur Clinique

👻 Score fantôme 1%

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Alira Health

Site WebLinkedInTous les Emplois

501 - 1000 employés

🏥 Santé

🏭 Fabrication

⚕️ Assurance santé

💰 €58 000 000 Venture Round en 2023-01

Healthcare • Manufacturing • Healthcare Insurance

Alira Health est un cabinet de conseil international qui accompagne les entreprises des sciences de la vie dans le développement de solutions innovantes en santé. L’entreprise est spécialisée dans un large éventail de services, notamment la recherche et le développement clinique, la conformité réglementaire et le conseil en management. Alira Health met l’accent sur l’engagement des patients, l’accès au marché et la mise en œuvre de solutions concrètes visant à améliorer les résultats de santé. Elle est engagée en faveur de la durabilité environnementale et participe activement à des actions auprès des communautés ainsi qu’à des initiatives ESG. Alira Health propose également des solutions technologiques, avec pour objectif d’améliorer la recherche en sciences de la vie grâce à l’empathie et à l’excellence scientifique.

Description

• Conduct site monitoring responsibilities for clinical trials independently • Provide oversight, leadership, and guidance to CRA teams • Ensure adherence to project scope, SOPs, timelines, budgets, protocol, GCP, and regulatory requirements • Review monitoring visit reports and conduct co-monitoring and evaluation visits • Ensure timely investigator site visits • Coordinate cross-functional issue resolution for clinical trial monitoring • Assist with Monitoring Plans, training presentations, ethics documents, and site contract negotiation • Provide monthly billing information to finance • Manage study budgets and act as sponsor referent for stand-alone projects • Perform qualification, initiation, interim, and close-out visits remotely and onsite • Prepare accurate monitoring visit reports covering site issues, resolutions, protocol deviations, study progress, and enrollment • Verify source documents and CRF data integrity • Perform quality control of eTMF/TMF documents and investigational product accountability • Review site regulatory binders • Maintain site contact, assess patient accrual, and respond to sponsor requests • Facilitate adverse event reporting and SAE reconciliation • Resolve discrepant data queries with in-house CRAs, CTC, and data management • Identify site issues and develop problem-solving strategies • Prepare study sites for audits • Mentor and train CRAs, including new-hire onboarding • Collaborate on CTMS development and maintenance • Manage conflicting priorities and perform additional assigned duties

🎯 Exigences

• Minimum 3 years of clinical monitoring experience in the pharmaceutical / biotechnology / CRO industry • Ability to autonomously manage monitoring activities • Oncology experience • Availability to travel in Belgium and Netherlands • Quality focused; careful, thorough, and detail-oriented • Strong organizational skills and ability to multi-task in a fast-paced environment • Ability to manage priorities, organize time, and solve problems • Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills • Ability to travel and manage stress • Professional, trustworthy, and disciplined • Ability to problem-solve unstructured or ambiguous challenges • Strong command of the local language, written and verbal, in the country where monitoring activities are performed • Excellent communication and interpersonal skills with customer service orientation • Good computer skills, including clinical trial management systems, clinical trial databases, and electronic data capture • Knowledge of clinical research, ICH GCP, and local regulations • Knowledge of regulatory and ethical requirements • Ability to establish and maintain positive relationships with Sponsor, Site, and Project Team members • Graduation in a scientific health field • Adequate English • Bachelor's degree in Biology, Biotechnology, Life Sciences, Pharmacy, or related scientific health field

🏖️ Avantages

• Remote work • Regular employment contract

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