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. 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 Purpose
ARTIDIS is a medical device start-up company that conducts clinical studies to validate and develop new cases for its products. Given that ARTIDIS's 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.
Duties and Responsibilities
- Accountable for the lead, management and coordination of all assigned clinical studies, from studz start-up to close out at a countrz level in accordance with ICH-GCP and applicable local regulations.
- Development and management of all applicable documentation, as well as any updates/amendments to those documents according to applicable requirements
- Collaborates with cross-functional stakeholders to ensure timely and on budget execution of clinical trial deliverables within the country
- Leading an international clinical operations team and coordinating and supervising external partner(s) ensuring consistent study execution.
- Accurate tracking of key study activities and maintenance study metrics for routine reporting.
- General oversight over clinical study management and provide operational expertise, program-level oversight, and leadership on clinical portfolio and study deliverables in accordance with ARTIDIS quality standards.
- Oversight of the study subject enrolment and clinical monitoring activities at study sites to assure compliance with all applicable requirements.
Qualifications
- Minimum 5 years of medical device clinical study management experience in a leading position.
- Experience of the entire scope of medical device clinical studies, from drafting study proposals, preparation of study-specific documents, preparation and submissions to regulatory authorities and ethic committees/institution review boards, study initiation, study conduct, and study close-out
- University degree in a scientific discipline or related field, or an equivalent combination of education and work experience.
- Advanced hands-on experience with guidelines related to GCP and applicability for medical devices and regulatory environment.
- Hands-on experience with regulatory guidelines and regulations and applicable GCP standards for medical devices.
- Excellent oral and written communication skills in English. Oral and written communication skills in German are a plus.
- Independent mindset, ability to self-organize and take ownership of assigned duties.
- Team player with a pragmatic approach and creative problem-solving capabilities.
- Thriving in a dynamic start-up environment, displaying a high level of flexibility, adaptability, and a hands-on mentality.
- Characterized by integrity, loyalty, discretion, and reliability.
Working Conditions
ARTIDIS 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.