About ARTIDISARTIDIS 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. The ARTIDIS nanotechnology platform integrates different types of clinical data into the ARTIDISNET digital platform, intended to allow physicians to significantly shorten the current diagnostic process 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 PurposeARTIDIS is a medical device start-up company that conducts clinical studies to validate and develop new cases for its medical products. Given that ARTIDIS's medical devices are unique, the clinical studies are designed and supervised directly by ARTIDIS. The Clinical Study Manager is an integral part of the Clinical Operations Team which manages planned and ongoing clinical studies. The Clinical Study Manager is responsible for overseeing the planning, implementation, and maintenance of clinical studies globally, as well as the development of required clinical documentation. He/she is responsible for ensuring that the study is performed in accordance with applicable regulatory, national, and contractual requirements. Additionally, he/she is responsible that the study conduct is in compliance with the approved study protocol and Good Clinical Practices (e.g., ISO 14155:2020, ISO 20916:2019, or ICH-GCP E6 (R2) as applicable) are followed.Duties and Responsibilities
Design, plan, and implement clinical studies for medical devices
Manage all aspects of clinical studies, including day-to-day operations
Provide study-specific training to the Clinical Operations Team and external partners
Initiate and coordinate study protocol development and other operational documents
Manage resources and timelines for study start-up, implementation, and close-out
Ensure proper setup and maintenance of sponsor files
Oversee subject enrollment and clinical monitoring activities at study sites
Monitor study progress to ensure compliance with protocol, QMS, and regulatory requirements
Identify and resolve issues that may impact study conduct, quality, timeline, or budget
Track key study activities and maintain study metrics for reporting
Manage payments to sites and vendors according to agreements
Handle safety documentation and reporting in compliance with protocol and regulatory requirements
Conduct remote data monitoring and on-site visits following national regulations and GCP
Act as a contact point with study sites and maintain communication records
Ensure completeness and up-to-date status of sponsor and site files prior to archiving
Perform site audits, including source document review when applicable
Plan and conduct internal and external meetings with study stakeholders
Comfortable with measurement procedures of the ARTIDIS Medical Device
Qualifications
University degree in a scientific discipline or related field, or equivalent combination of education and work experience
Minimum 5 years of medical device clinical study management experience in a leading role
Proficiency in all aspects of medical device clinical studies, from proposal drafting to study close-out
Advanced knowledge of GCP guidelines and their application to medical devices
Hands-on familiarity with regulatory guidelines and standards for medical devices
Excellent English communication skills; German proficiency is advantageous
Independent and organized, capable of taking ownership of assigned tasks
Collaborative team player with creative problem-solving skills
Comfortable in a dynamic startup environment, demonstrating flexibility and adaptability
Possesses integrity, loyalty, discretion, and reliability
Working ConditionsARTIDIS is a start-up company with an intrinsically motivated international team. Our company offers an excellent environment for fostering professional development while ensuring 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 will be rewarded with challenging tasks, the possibility of taking responsibility, a highly driven team, and working serving a significant purpose. The job position comes with a competitive salary and a bonus for outstanding performance. The job involves 20% travel.
