Clinical Trial Manager II

🕒 il y a 1 mois

🇭🇺 Hongrie – Télétravail

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

🧪 Chercheur Clinique

👻 Score fantôme 31%

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🗣️🇺🇸🇬🇧 Anglais requis

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Syneos Health

10 000+ employés

🏥 Santé

💼 Conseil

📦 Logistique

Healthcare • Consulting • Logistics

Syneos Health est une organisation de solutions biopharmaceutiques entièrement intégrée et leader, conçue pour accélérer le succès des clients. Ils transforment des intuitions cliniques, des affaires médicales et commerciales uniques en résultats pour répondre aux réalités du marché moderne. En utilisant des technologies avancées et des perspectives, Syneos Health collabore avec les clients pour accélérer la livraison de thérapies importantes aux patients dans le monde entier, offrant des services qui couvrent tout le spectre du clinique au commercial.

Description

• Responsible for all aspects of the development, coordination, and implementation of Phase 1 clinical research studies • Collaborates with the principal investigator and liaises between research subjects, client teams, investigators, and clinic operations teams • Tracks study progress in alignment with project milestones, client deliverables, and budget • Follows applicable regulations globally and by region • Supervises experienced support employees and/or entry individual contributors • Delivers operational results that have moderate impact on the immediate achievement of results for the team. • Reviews the study scope of work, budget and protocol content • Ensures the clinical project team is aware of the contractual obligations and parameters • Escalates to the project manager any risks to clinical trial management deliverables • Provides solutions for obstacles in protocol execution and site management.

🎯 Exigences

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience • Demonstrated ability to lead and align teams in the achievement of project milestones • Demonstrated capability of working in an international environment. • Demonstrated expertise in site management and monitoring (clinical or central) • Preferred experience with risk-based monitoring • Demonstrates understanding of clinical trial management financial principles and budget management • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements • Must demonstrate good computer skills • Good communication, presentation and interpersonal skills among project team and with sites • Strong conflict resolution skills • Demonstrated ability to apply problem solving techniques to resolve complex issues, and apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical research project. • Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues. • Moderate travel may be required, approximately 20%

🏖️ Avantages

• We are passionate about developing our people, through career development and progression • supportive and engaged line management • technical and therapeutic area training • peer recognition and total rewards program • We are committed to building an inclusive culture – where you can authentically be yourself.

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