Duties and responsibilities
- 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
- Provide training and lectures for various courses related to clinical research
Requirements
Degree in a scientific fieldRelevant professional experience, ideally with a minimum of 2 years of clinical trial monitoringFull professional proficiency in written and spoken German and English, working knowledge of French or ItalianExcellent understanding of ICH-GCP guidelines, ISO 14155, and applicable regulationsStrong understanding of diverse medical therapeutic areas, including familiarity with medical terminologyExperience with R programming preferredExcellent verbal and written communication skillsStrong critical thinking and analytical skillsOutstanding organizational skills with a proactive, solution-oriented mindsetProven ability to deliver high-quality results within established timelinesAbility to manage multiple projects simultaneously and prioritize effectivelyWillingness and availability to travel, both nationally and internationallyConfidence and willingness to prepare and deliver presentationsWe 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 homeOpportunities 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.Are you interested? Then please send us your complete application to HR Administration hr.dcr@unibe.ch.
Required application documents :
CVMotivation letterAcademic transcript / record of gradesMentioning your earliest possible start dateNote : Only complete applications will be considered. j4id10033079a j4it0103a j4iy26a