Spineart is looking for an experienced Project Manager to lead Clinical Trials.
• Lead the assigned clinical trials from start-up to closure.
• Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines.
• Coordinate the study protocol and report development.
• Anticipate potential issues and risks within the clinical studies, create contingency plans and drive solution implementation.
• Manage site selection process and site communication throughout the studies.
• Patient enrolment focus and addressing patient enrolment risks
• Design, review and approve trial related documentation.
• Interfaces with clinical data management and statistics in developing case report forms, managing data clean-up, and analysing study data.
• Manage Contract Research Organizations (CROs), image laboratories, etc.
• Coordinate co-monitoring with CRAs when required
The Clinical Project Manager is responsible for leading, planning, implementing and delivering post market clinical trials on medical devices used in Spine surgery, to ensure that studies are carried out according to the protocol, SOPs, applicable regulations and principles of Good Clinical Practice.
• University degree or equivalent in Life Sciences.
• Mininum 6-8 years of experience as a Clinical Trial Project Manager in the Medical Device Industry. Spine experience is desirable.
• Excellent Project Management skills, including clear and proactive communication, budgeting, timelines, issues and risk management.
• Experience in coordinating protocol development.
• Experience in safety reviews and report writing is desirable.
• Experience in management of CROs, vendors and consultants.
• Fluent in English and French. German is required.
• Has the interpersonal skills necessary to build long-lasting and positive relationships with multiple stakeholders.
• Organized with focus on high quality, ability to prioritize competing demands and meet deadlines.
• Willingness to travel (approximately 25%).
The people we want to engage have a positive, proactive, collaborative, self-driven personality. We can offer a flexible and trust-based working environment with exciting projects among competent colleagues where your knowledge, experience and contribution are valuable and highly appreciated.
If you match with our requirements and that you are interested in this challenging career opportunity, in a dynamic growing and technology driven environment, we look forward to receiving your complete application, incl. a motivation letter.