Clinical Site Manager at ProQR Therapeutics
ProQR Therapeutics is a clinical-stage biotech company listed on NASDAQ with offices in Leiden, the Netherlands and Cambridge, Massachusetts, US. ProQR is focused on the development of game changing RNA therapies for severe genetic rare diseases. Our mission is to help patients by creating new medicines. A team of 160 enthusiastic ProQRians from all walks of life and more than 30 different nationalities is up to this challenge. We have the passion and commitment to make a difference in the lives of the patients we serve.
ProQR is currently looking for a Clinical Site Manager (Full-time) to join our team. The Clinical Site Manager will be responsible for building and maintaining clinical trial site relationships and act as the critical contact between clinical trial sites and ProQR for all operational issues.
• Serve as a professional, reliable partner for ProQR clinical trial sites on all activities related to clinical trial operations
• Serve as a single point of contact for sites related to operational issues across all programs/studies
• Develop a deep knowledge of assigned clinical trial sites operational capabilities
• Act as the key point of contact for clinical trial sites for all operational issues that are not quickly resolved through established pathways
• Navigate within ProQR and vendors to identify issues, root cause and expedite resolution of issues
• Establish and maintain excellent relationships with clinical trial site staff and conduct regular site visits
• Identify areas for improvement at ProQR and within vendors. Act as a champion for leading process changes that drive improved results in clinical trial execution
• Provide ProQR teams with insights into regional, country and site level processes and requirements
• Build a knowledge management repository for regional/country/site specific information related to clinical trial execution
• Support activities related to identification, evaluation and selection of clinical trial sites
• Provide input into regional/country/site recruitment forecasts and methodologies, monitor performance and take appropriate action to beat/maintain timelines
Location: This position will be based at our Leiden Office, NL but European travel to clinical trial sites will be required, at times in excess of 50% of the time.
We expect our Clinical Site Manager to:
• Have a Bachelor’s degree or equivalent and proven experience in Clinical Operations
• have good working knowledge of ICH-GCP, , IRB/IEC and other applicable regulations/guidelines
• have notable clinical trial experience with significant site staff interaction is required.
• have a Medical/Healthcare background and experience in Ophthalmology is preferred
• have significant experience working as a study coordinator/CTC/CRA/etc required
• have a high level of professionalism and maturity
• be proficient working in a highly regulated environment
• have outstanding collaboration skills
• be self-motivated with proactive issue monitoring and management including risk assessment and contingency planning
• Have excellent verbal and written communication in English
• Preferably have verbal and written communication skills in another European language(s)
• Have excellent critical thinking, problem-solving skills and operational expertise
• Be relentless in your pursuit to provide ProQR sites with an exceptional experience
ProQR as an employer
As an employer, we are a true believer of the value of a workforce in which people from diverse backgrounds are encouraged to develop themselves, personally and professionally. We believe that happy and energized people, working well together in an environment in which they thrive, will do phenomenal and awesome things.
We are committed to ensure that no employee, candidate or job applicant receives less favorable treatment on the grounds of race, age, disability, pregnancy, religion, gender identity and expression, sexual orientation, marriage or civil partnership status. At ProQR we want to create an inclusive culture where everyone can be valued for who they are and in which individual differences and the contributions in all forms are recognized and valued.
We offer an exciting and innovative working environment in a very committed organization, with the following benefits:
• A competitive salary
• 8% holiday allowance
• 30 vacation days
• An annual performance bonus
• Stock options
• A premium-free pension plan
• A commuting allowance
• A subsidized staff restaurant
• Flexible working arrangements
• Unlimited (un)healthy snacks and drinks
• Employee events (boot camp, chair massage and other social events)
Do you think you can contribute in achieving our mission? If so, we’re looking forward to receiving your application by filling out our application form.
Please apply as soon as possible if you are interested in this position.
You can contact Laura Faber via email@example.com if you have any questions.