(Senior) Clinical Trial Monitor 80-100%
Universität Bern
Date de publication :
08 avril 2025Taux d'activité :
80 – 100%- Lieu de travail :Bern
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Résumé de l'emploi
Le Département de recherche clinique (DCR) de l'Université de Berne, soutient les chercheurs cliniques. Rejoignez une équipe dynamique avec un bon équilibre travail-vie personnelle.
Tâches
- Assurer le contrôle qualité des essais cliniques nationaux et internationaux.
- Collaborer avec les équipes d'étude pour optimiser la sécurité des patients.
- Former et encadrer des cours liés à la recherche clinique.
Compétences
- Diplôme en médecine, sciences ou domaine connexe; un doctorat est un atout.
- Excellente compréhension des directives ICH-GCP et des réglementations.
- Capacité à communiquer efficacement en plusieurs langues.
Est-ce utile ?
Department of Clinical Research
Employment at the earliest opportunity
The Department of Clinical Research (DCR) is an academic center and umbrella organization supporting clinical researchers at the University of Bern and the University Hospitals consisting of strong Research Units, the Clinical Trial Unit (CTU), the Clinical Investigation Unit (CIU), and two new subunits in 2025, a Medical Data Science Unit and a Gender Medicine Unit.
DCR is a diverse department that provides central organization for expertise, innovation, leadership, contemporary pedagogy, and centralized facilities for supporting clinical researchers. DCR offers clinical researchers full support from study design to study implementation. DCR works across multiple collaborations with the Medical Faculty of the University of Bern and the University Hospitals.
We are looking for a (Senior) Clinical Trial Monitor.
Tasks
- Responsible for the quality control of clinical trials phase I to IV, both nationally and internationally
- Ensure study sites conduct clinical trials in accordance with the protocol, ICH-GCP guidelines, and the applicable regulations
- Perform on site and remote monitoring activities from study initiation to study completion
- Conduct central data monitoring
- Identify, assess, and resolve any site-related issues to ensure smooth trial progress and maintain high data quality
- Document monitoring activities thoroughly, including monitoring reports, protocol deviations, and action items to be addressed
- Collaborate with study teams, investigators, and sponsors to address trial-related concerns and optimize patient safety and trial performance
- Review and evaluate trial data to detect trends, discrepancies, and potential issues
- Perform investigational product (IP) inventory, reconciliation and review storage and security
- Additional responsibilities : Provide training and lectures for various courses related to clinical research
Requirements
- Degree in medicine, science, or a related field; a PhD is advantageous
- Relevant professional experience, ideally with minimum 2 years of clinical trial monitoring preferred
- Proficiency in both written and spoken German and English; additional fluency in French or Italian is highly desirable
- Excellent understanding of ICH-GCP guidelines and applicable regulations
- Strong understanding of diverse medical therapeutic areas, including familiarity with medical terminology
- Proven ability to communicate effectively, both verbally and in writing
- Well-developed critical thinking and analytical skills
- Exceptional organizational and problem-solving abilities
- Demonstrated capacity to deliver high-quality results within established timelines
- Ability to manage multiple projects simultaneously and prioritize effectively
- Willingness and availability to travel, both nationally and internationally
We offer
- An interesting and versatile role in a growing department, contributing to the successful development of the DCR.
- An international and dynamic environment with a motivated and diverse team, dedicated to high quality research.
- A good work-life balance thanks to flexible working hours and the possibility of working from home
- Opportunities for further training and programs within the University and a wide range of sports activities through 'Uni Sport'
- Salary and comprehensive social benefits according to cantonal guidelines.
Contact
If you have any inquiries, please contact Sophie Mermoud, a.i. Head of Monitoring Division, at E-Mail schreiben.
Are you interested? Then please send us your online application to HR Administration
(E-Mail schreiben) by May 8th, 2025, at the latest.