ARTIDIS AG is a clinical stage health-tech start-up 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, allowing physicians to significantly shorten the current diagnostic process and bringing benefit to both the patient and the healthcare system. ARTIDIS enables professionals to design personalised cancer treatment plans tailored to the individual patient needs and desired outcomes.
ARTIDIS as a Medical Device Start-Up conducts clinical studies for the validation of its medical products and development of new use cases for its products. As the medical products of ARTIDIS are unique, the Clinical Studies are designed and supervised directly by ARTIDIS. The Clinical Study Manager is part of the Clinical Operations Team that manages the clinical studies by ARTIDIS.
Duties and Responsibilities
- Ensure that national and international clinical studies are conducted in compliance with protocol requirements, FDA regulations and Good Clinical Practice of ARTIDIS Study Sites
- Participates in the design, planning, implementation, overall direction and management of clinical research projects
- Manage all aspects of clinical study execution, including oversight and day-to-day management
- Ensure Clinical Operations team and external partner receive study specific training (identify site staff training needs, support the development of training materials, and deliver training)
- Initiate, coordinate, and take responsibility for protocol development and development of other operational documents (e.g., SOP, WI, Forms) as well as any updates/amendments to those documents according to regulatory and GCP requirements
- Facilitate negotiation and finalization of investigator site agreements and budgets
- Manage resources and timelines associated with all study start-up and implementation activities; including investigator agreements, central IRBs, and contractual agreements
- Ensure the proper set up and maintenance of the Trial Master File (TMF), including periodic review
- Oversight of the study subject enrolment and clinical monitoring activities at study sites
- Monitor study progress to assure compliance with protocol requirements, FDA regulations and Good Clinical Practice of ARTIDIS Study Sites
- Identify and resolve issues, which may impact the delivery of the study or to the necessary quality, timeline or budget objectives
- Accurately track key study activities (eg., country startup, site activation, patient recruitment, patient status, data collection, data review, etc.) and maintain study metrics for routine reporting to the internal project team and management
- Conduct remote data monitoring and on-site visits (training, monitoring, close-out) in accordance with Federal regulations, ICH Good Clinical Practices guidelines and standard operating procedures
- Perform site audits that include source document review
- Facilitate study close out activities through completion of Clinical Study Report
Contribute to the planning and conduct of internal and external meetings (e.g., Investigator/Monitors meeting)
- Be familiar with measurements procedures of the ARTIDIS Medical Device
- Minimum 5 years clinical study management (working knowledge of medical device validation studies and respective regulations, including ICH and GCP guidelines)
- Experience with budget management and oversight
- Apply your organizing and problem-solving skills to plan and run efficient operational aspects of a study
- Demonstrate agility and ability to perform in a highly fast-paced environment where cross-team collaboration is crucial
- Excellent oral and written communication skills in English, same in German is a plus
- Bachelor degree in a scientific discipline or related field required, or equivalent combination of education and work experience
- Ability to work in an agile and rapid changing Start-Up environment
The environment is a typical start-up with an intrinsically motivated international team. Our office is a great 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 a work serving a highly meaningful purpose. The job position comes with a competitive salary and a bonus for outstanding performance.
The Job involves 10-20 % traveling.