Senior Clinical Trial Monitor

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 field
• Relevant professional experience, ideally with a minimum of 2 years of clinical trial monitoring
• Full professional proficiency in written and spoken German and English, working knowledge of French or Italian
• Excellent understanding of ICH-GCP guidelines, ISO 14155, and applicable regulations
• Strong understanding of diverse medical therapeutic areas, including familiarity with medical terminology
• Experience with R programming preferred
• Excellent verbal and written communication skills
• Strong critical thinking and analytical skills
• Outstanding organizational skills with a proactive, solution-oriented mindset
• Proven ability 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
• Confidence and willingness to prepare and deliver presentations

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.

Are you interested? Then please send us your complete application to HR Administration hr.dcr@unibe.ch.

Required application documents:

• CV
• Motivation letter
• Academic transcript/record of grades
• Mentioning your earliest possible start date