Medical Monitor – Oncology

🕒 il y a 7 jours

🇳🇱 Pays-Bas – Télétravail

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

🧪 Chercheur Clinique

🗣️🇺🇸🇬🇧 Anglais requis

D'où vient cette offre

Publiée sur la page carrières de PSI CRO AG, pas via un site d'emploi

Repérée par Remote Rocketship il y a 7 jours

Toujours ouverte sur le site de PSI CRO AG. Vérifiée il y a 14 minutes.

Logo of PSI CRO AG

PSI CRO AG

1001 - 5000 employés

Fondée en 1996

🏥 Santé

💼 Conseil

📦 Logistique

Healthcare • Consulting • Logistics

PSI CRO AG est une Contract Research Organization (CRO) internationale spécialisée dans la conduite d’essais cliniques. L’entreprise se concentre sur la réalisation d’essais pivots de Phase 2 et 3 dans de multiples aires thérapeutiques, notamment les maladies inflammatoires chroniques de l’intestin, l’oncologie, l’hématologie, les maladies infectieuses, la sclérose en plaques et les maladies rares. PSI s’appuie sur une plateforme technologique propriétaire pour la planification des essais et le suivi financier, garantissant des études menées dans les délais et le budget impartis. L’entreprise est reconnue pour son expertise, sa qualité, sa compatibilité opérationnelle et sa fiabilité, et a reçu à plusieurs reprises les CRO Leadership Awards.

Description

• Serve as primary medical point of contact for clinical trial sponsors, internal project teams, investigators, and trial sites • Provide medical oversight throughout clinical trials in accordance with protocols, regulations, and ICH-GCP requirements • Respond to medical questions from investigators, sites, sponsors, project teams, and third-party vendors • Provide medical input into eligibility assessments, protocol deviations, participant safety issues, and trial-specific medical matters • Contribute medical expertise to clinical development plans, protocols, investigator brochures, informed consent documents, annual reports, clinical study reports, patient narratives, and scientific presentations • Review and assess clinical and safety data to support participant safety and identify medically relevant trends, risks, or quality concerns • Prepare and deliver medical and therapeutic area training to investigators and study teams • Support medical data review and assessment of aggregated clinical trial data • Participate in bid defense meetings and proposal activities • Support Pharmacovigilance activities • Identify medical trial risks and collaborate on mitigation and escalation measures • Support or participate in advisory boards, safety monitoring boards, and other medical or scientific committees • Ensure trial conduct and medical oversight comply with approved protocols, regulatory requirements, and quality standards

🎯 Exigences

• Medical Doctor degree • Board certification in Oncology • Previous experience as a practicing Oncologist • Previous experience in clinical research or the pharmaceutical or CRO industry is a plus • Full professional proficiency in written and spoken English • Strong medical judgement, analytical thinking, and attention to detail • Clear communication and presentation skills, with the ability to explain complex medical information to different stakeholders • A collaborative and solution-oriented approach to working within international, cross-functional teams • Proficiency in Microsoft Office applications • Confidence working with clinical trial systems and digital collaboration tools

🏖️ Avantages

• International team of medical professionals • Opportunity to apply oncology expertise across global studies • Collaboration with experienced colleagues • Opportunity to contribute to bringing new treatment options to patients

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