Description
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 sophie.mermoud@unibe.ch.
Are you interested? Then please send us your online application to HR Administration
(hr.dcr@unibe.ch) by May 8th, 2025, at the latest.