What are the responsibilities and job description for the Clinical Study Manager position at ARTIDIS?
About ARTIDIS
ARTIDIS AG is a clinical-stage health-tech start-up company founded in Basel, Switzerland that has developed the first nanomechanical biomarker for cancer diagnosis and treatment optimization. Our nanomechanical biomarker, based on the direct physical measurement of solid tissues, opens a new dimension in understanding cancer and tissue in general. The ARTIDIS nanotechnology platform integrates different types of clinical data into the ARTIDISNET digital platform, intended to allow physicians to significantly improve treatment planning, as well as shorten the time to diagnosis and therefore and benefit both the patient and the healthcare system. ARTIDIS intends to enable professionals to design personalized cancer treatment plans tailored to individual patients' needs and desired outcomes.
Job Purpose
ARTIDIS conducts clinical studies to develop and validate its unique medical products. These studies are designed and supervised by ARTIDIS without the involvement of a CRO.
As a start-up, we are driven by an innovative mindset and continually seek to overcome traditional boundaries. We are constantly developing, refining and improving our process to achieve the most effective and groundbreaking strategies. This position requires the employee to excel in such an environment. The effort will be rewarded with challenging tasks, the opportunity to take on significant responsibility, collaborate with a highly driven team, and the chance to revolutionize our understanding of cancer.
Duties and Responsibilities
- Design, plan, implement, and execute clinical studies for medical devices, including day-to-day oversight.
- Manage resources and timelines for all study activities from start-up to close-out, monitoring progress, tracking key activities, and managing the budget.
- Initiate, develop, and manage all study documentation and updates/amendments in accordance with regulatory and GCP requirements.
- Oversee the distribution and tracking of investigational products and study supplies, ensuring sites have the required products at all times.
- Maintain active internal and external communication with study stakeholders and sites to ensure a professional and collaborative working environment.
Qualifications
- Minimum of 2 years of experience in directly managing medical device clinical studies without a CRO between sponsor and investigator, preferably in IVDs
- Comprehensive knowledge of all aspects of clinical studies, including drafting proposals, preparing documents, regulatory submissions, study initiation, conduct, and close-out.
- Strong experience with GCP guidelines and medical device regulations.
- Excellent communication skills in English; German is a plus.
- Independent and self-organized, with a strong sense of ownership.
- Flexible and adaptable, willing to go beyond the job description to achieve goals, not confined to a corporate mindset.
- Innovative mindset to improve existing processes and effectively solve problems
Working Conditions
The environment is a typical start-up with an intrinsically motivated international team. Our company is an excellent place for rapid advancement and offers a promising opportunity to learn and share know-how in a very agile environment. The position requires the employee to go the extra mile when needed. We are looking for a team player who appreciates direct communication. The effort is rewarded with challenging tasks, the possibility to take responsibility, a highly driven team, and work serving a significant purpose. The job position comes with a competitive salary and a bonus for outstanding performance. A hybrid setup is possible. The job involves approximately 20% travel.