Medical Monitor Oncology

PSI CRO; Paris; Sur place; EUR 60 000 - 100 000; Plein temps

Résumé du poste

Une organisation de recherche clinique de premier plan recherche un Moniteur Médical pour fournir des conseils médicaux sur les études cliniques. Dans ce rôle, vous serez le point de contact médical pour les équipes internes et les sites d'étude, garantissant la sécurité des patients tout en respectant les protocoles et les directives GCP. Vous collaborerez avec divers départements pour préparer des documents scientifiques et vous participerez aux activités de pharmacovigilance. Rejoignez une équipe internationale de professionnels de la santé et contribuez à l'innovation médicale tout en développant votre carrière dans un environnement stimulant.

Qualifications

• Certification de fellowship en oncologie requise.
• Expérience pratique d'au moins 10 ans en oncologie.

Responsabilités

• Point de contact médical pour les équipes de projet et les sites d'étude.
• Collaborer à la préparation de plans de développement clinique et de rapports.

Connaissances

Compétences en communication

Compétences analytiques

Résolution de problèmes

Travail en équipe

Orientation vers les détails

Formation

Certification de fellowship en oncologie

Expérience en tant qu'oncologue

Outils

Applications MS Office

Description du poste

PSI is a leading Contract Research Organization with more than 25years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

Job Description

PSI Medical Monitorsprovide medical input to global clinical studies and advise the teams and business partners, while always focusing on patients' safety and well-being.

Responsibilities:

• Medical point of contact for internal project team, study sites and study sponsor for medical matters related to the conduct of clinical trials per protocol and per GCP guidelines
• Advise clients, project teams, sites, data safety monitoring boards, regulatory agencies and third-party vendors on medical matters
• Collaborate with internal departments in the preparation of clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, narratives, and different scientific presentations
• Review and analysis of clinical data to ensure the safety of study participants in clinical studies
• Ensure that the reported data is accurate, complete, and verifiable, and that the conduct of the trial is in compliance with the currently approved protocol/amendments
• Address safety issues across the study from sites and the study team
• Supports and/or performs medical data review of the operational clinical trial database
• Participate in meetings with clients and Investigators
• Assist in Pharmacovigilance activities
• Identify Program risks, and create and implement mitigation strategies with Clinical Operations
• Organize and lead clinical development advisory boards and safety monitoring boards
• Ensure Study team compliance with FDA, EMEA, ICH and GCP guidelines
• Review and sign off clinical medically relevant documents.

Qualifications

• Oncology Fellowship certification is a must
• Prior and wide experience as a practicing Oncologist (minimum of 10years)
• Full working proficiency in English
• Proficiency with MS Office applications
• Communication, presentation and analytical skills
• Problem-solving, team and detail-oriented

Additional Information

As part of PSI's Medical Monitoring team, you will join our international group of medical professionals, build a career on the frontline of medical science and use your knowledge and expertise to help bring new medications to patients that need them.