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.
Our Clinical Operations department is currently looking for a highly motivated (Senior) Clinical Trial Manager (full-time) to strengthen our team.
Location: Leiden (Netherlands) or North America
We expect our (Sr) Clinical Trial Manager to:
• Responsible for the day-to-day logistics of assigned clinical studies including project planning, budget, resource management and contract research organization management
• Act as a cross functional liaison to ensure study plans align with business development strategies and to create excellence in Clinical Operations
• Work on problems of diverse scope in which analysis of situation or data requires evaluation of identifiable factors
• Exercise sound judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
We want our (Sr) Clinical Trial Manager to have hands-on experience with the following essential responsibilities:
• Overseeing daily operations of one or more clinical studies including project planning, budget, resource management and contract research organization management
• Developing study related documents and provides guidance for the clinical sites to establish protocol adherence
• Writing routine and ad hoc project updates, as needed, and coordinate project meetings, information and timelines to assure deadlines are achieved
• Ensuring that all aspects of the assigned clinical studies are in compliance with ICH, GCP and applicable regulatory requirements and that reported study data are accurate, complete and verifiable from source documentation
• Participating in the assessment and selection of vendors such as contract research organizations, central laboratories, and other specialty service providers, as needed
• Identification and selection of clinical investigators and study sites
• Overseeing study management, including budget and contract negotiations, study material preparation, study status tracking, report review and monitoring
• Working closely with the contract research organization team(s) to ensure data entry and site monitoring practices are in line with study requirements
• Represent the company with a high level of integrity and professionalism
• Adhere to company’s policies and support management decisions and goals in a positive, professional manner
• Perform other duties as assigned
Skills that are required for making the difference:
• An understanding of and experience in the drug development process is required including: initiation procedures, clinical monitoring functions, drug safety reporting, data flow from external sites to internal processing/review/query resolution, data analysis and study report generation
• Thorough knowledge of medical terminology
• Able to recognize needs, find solutions and take initiative to address in a pro-active manner
• Excellent interpersonal and professional skills are mandatory
• Strong organizational and time management skills
• Excellent communication skills, both oral and written. Adjusts content and style for audience; effectively delivers key messages; able to manage and communicate with cross-functional teams and stake holders
• Fluency in English is required
• Extensive computer skills, including the use of Microsoft Office. Requires strong Word processing skills
• Experience with influencing and negotiating to achieve team delivery; flexible, proactive and solution-focused
• Excellent planning and organizational skills
• High level of initiative and ability to work independently; self-motivated and achievement driven
• Strong research and analytical skills
• Able to distill complex information from multiple sources and draw meaningful conclusions and insights
• A nice person :-)
Qualifications that are required for making the difference:
• Minimum RN or Bachelor’s degree in a scientific discipline and at least five (5) years’ experience in managing clinical studies
• Ophthalmology experience will be an advantage
• Ability to travel internationally required
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 Yessica De Brouwer via email@example.com if you have any questions.
Please note that a screening is part of our selection procedure.