Senior Clinical Trial Manager – Oncology

🕒 il y a 17 jours

🇵🇱 Pologne – Télétravail

⏰ Temps Plein

🟠 Senior

🧪 Chercheur Clinique

👻 Score fantôme 10%

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🗣️🇺🇸🇬🇧 Anglais requis

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Logo of Worldwide Clinical Trials

Worldwide Clinical Trials

1001 - 5000 employés

🏥 Santé

💼 Conseil

📦 Logistique

Healthcare • Consulting • Logistics

Worldwide Clinical Trials est une organisation mondiale de recherche contractuelle (CRO) qui offre des services complets d'essais cliniques. Ils se spécialisent dans le soutien aux études dans divers domaines thérapeutiques tels que l'oncologie, la cardiologie et les maladies rares. Avec plus de 30 ans d'expérience, Worldwide Clinical Trials met l'accent sur un soutien personnalisé et des solutions sur mesure tout au long du cycle de développement des médicaments. Leurs services incluent la surveillance clinique, la gestion des données, le recrutement de patients et le conseil réglementaire, garantissant précision et attention sur-mesure pour chaque essai clinique.

Description

• Provide leadership and direction to clinical site management team members from study start through closure • Oversee regional CTMs and coordinate efforts across the CTM team • Represent Site Management issues at Sponsor, Investigator, and bid defense meetings • Act as the main point of contact for study activities • Contribute to the overall project plan and formulate global monitoring strategies across assigned regions • Assign sites on behalf of the sponsor • Assume a dual PM/CTM role when needed • Develop, maintain, and ensure compliance with Clinical Monitoring Plans, including budgets, study tools, and site visit reports • Review protocol deviations, out-of-scope items, and action items • Train and manage the CRA team on clinical aspects of the study • Participate in recruitment strategy development and implementation • Forecast site visits with the CRA team to ensure staffing needs and address backlogs • Mentor CTMs when needed • Perform co-monitoring visits • Review and finalize trip reports according to WCT SOPs • Support study teams during healthcare authority inspections or sponsor audits

🎯 Exigences

• Excellent interpersonal, oral, and written communication skills in English and in local language • Ability to lead and motivate a team remotely • Initiative and problem-solving skills • Strong customer focus and professional interaction with sponsors • Proficiency in Microsoft Office, CTMS, and EDC systems • Four-year college curriculum or equivalent with a major concentration in biological, physical, or health studies and minimum 4 years as a Senior Clinical Research Associate or equivalent • OR two-year college curriculum or equivalent education/training and minimum 6 years as a Senior Clinical Research Associate • Minimum 2 years of relevant experience as a CTM/LCRA or equivalent, including overseeing a CTM team • Experience working with Oncology studies is required • Willingness to travel

🏖️ Avantages

• Diverse and inclusive work environment • Supportive, team-oriented atmosphere • Hands-on, accessible leadership • Equal employment opportunities • Employee experiences where everyone is respected and has access to equal opportunity

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