Clinical Trial Manager, dedicated

🕒 il y a 21 jours

🇩🇪 Allemagne – Télétravail

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

🧪 Chercheur Clinique

👻 Score fantôme 10%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.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

Site WebLinkedInTous les Emplois

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

• Provide site management oversight, clinical monitoring, and central monitoring deliverables • Focus on patient safety, protocol/GCP/regulatory compliance, and data integrity • Oversee site interactions from activation through closeout, including recruitment and investigator payments when applicable • Identify clinical trial risks and develop or implement mitigations, including RACT-related risks • Review study scope, budget, protocol content, and contractual obligations • Escalate timeline, quality, budget, and out-of-scope risks to the project manager • Participate in and present at key meetings, including Kick Off Meetings • Serve as an escalation point for investigator site communications and accompany CRAs to sites when needed • Coordinate with Study Start Up, Patient Recruitment, Data Management, and other functions to meet study milestones • Develop and maintain clinical study tools and templates, including the Clinical Monitoring Plan • Ensure CTMS, dashboards, and other systems are configured and available, including UAT and audit trail reviews • Coordinate protocol, CRF, dashboard, SOP, clinical plan, data plan, and timeline training for study teams • Oversee CRA and Central Monitor resourcing, assignments, conduct, compliance, and deliverable quality • Review oversight dashboards and clinical trial systems including CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS, and central monitoring dashboards • Ensure monitoring strategy, CMP/SMP, risk plans, and protocol requirements are understood and followed • Review site and central monitoring documentation and ensure timely, compliant delivery • Provide client, project management, and leadership status updates on deliverables and risks • Support inspection readiness, corrective action plans, data cuts, and database lock deadlines • Provide staff performance feedback to line managers • Coordinate clinical activities across portfolios and mentor CTMs when 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 when identifying issues • 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