Clinical Trial Manager II

🕒 il y a 3 mois

🇵🇱 Pologne – Télétravail

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

🧪 Chercheur Clinique

👻 Score fantôme 55%

Ce que ça veut dire : la probabilité que personne ne recrute vraiment pour cette offre.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Syneos Health

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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

• Manage all aspects of the development, coordination, and implementation of Phase 1 through Phase 4 clinical research studies • Collaborate with principal investigators, research subjects, client teams, investigators, and clinic operations teams • Plan logistics and resource usage • Track study progress against milestones, client deliverables, budgets, and applicable regulations • Provide site management oversight, clinical monitoring, and central monitoring deliverables • Oversee site interactions from post-activation through site closeout, including recruitment and investigator payments • Identify clinical trial risks and implement mitigations • Review scope of work, budgets, protocols, and contractual obligations • Escalate risks affecting timelines, quality, budget, or contracted scope • Participate in and present at key meetings • Coordinate handoffs with Study Start Up, Patient Recruitment, and Data Management • Develop and maintain clinical study tools and templates, including Clinical Monitoring Plans • Oversee CTMS, dashboards, systems setup, user acceptance testing, access, and audit trail reviews • Coordinate protocol-specific and study-team training • Oversee CRA and Central Monitor resourcing, assignments, conduct, and delivery risks • Review monitoring documentation and ensure compliance with company and sponsor specifications • Provide status updates and solutions to clients, project management, and leadership • Support inspection readiness, corrective action plans, data cuts, and database lock deadlines • Provide performance feedback to line managers • Coach and mentor CTMs as assigned

🎯 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 • Understanding of clinical trial management financial principles and budget management • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements • Good computer skills • Strong conflict resolution skills • Ability to apply problem-solving techniques to resolve complex issues and use a risk management approach • Critical thinking to determine causes and appropriate solutions • Moderate travel may be required, approximately 20%

🏖️ Avantages

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Reasonable accommodations when appropriate

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