Your main tasks
* Responsible for overseeing global clinical trials, ensuring compliance with ISO standards, the Declaration of Helsinki, and relevant national laws and regulations. This includes adherence to EU Regulation 7/ (MDR), as well as adhering to clinical trial standards as governed by the Food and Drug Administration (FDA)
* Responsibility for adherence to timelines, milestones, and task completion of clinical trials
* Supervising and supporting CROs and trial centers in the preparation and conduct of clinical studies in compliance in close collaboration with medical experts and external advisors
* Planning, coordination, and conduct of audits according to predefined audit plans and checklists at CROs and trial sites to ensure compliance with GCP guidelines, internal quality standards, study protocols, and regulatory requirements
* Establish and maintain a constructive relationship with local & international opinion leaders, trial centers, CROs, and other third parties
* Effective communication with internal and external stakeholders, including regulatory authorities, ethics committees, CROs, investigators, and advisors
* Contribution to the scientific evaluation and interpretation of study results, including the preparation of reports and publications
* Organization and implementation of training measures for Ypsomed employees and study team members to ensure compliance with study standards and guidelines
* Medical-scientific support for internal R&D, Marketing & Sales departments
* Writing of Clinical Development Plans / Clinical Evaluation Plans and Reports, Post-Market Clinical Follow-Up Plans (and Reports) for new products and new indications
Your profile
* Master of Science (MSc) degree in a natural science discipline or in the health sector, or equivalent qualification
* Doctorate (PhD or Dr.) is an advantage
* >2 years of experience in planning and monitoring clinical trials
* Very good knowledge of standard requirements ISO-GCP and 7/ for Medical Devices (MDR), as well as applicable FDA regulations
* Sound knowledge of clinical research/testing methodology
* Knowledge of the medical device industry and strong scientific understanding (experience in the field of medical devices, at least Class II)
* Fluent in written and spoken English
Your benefits
* Shiftwork, annual working hours, part-time
* FlexWork: Work where and when you want (in Switzerland)
* Up-to-date work environment: Up-to-date production, offices, break areas
* Pension fund: Ypsomed covers % of the pension contributions
* Mobility support: Charging stations, Swiss Half Fare Card, parking, close to public transport
* Free sport facilities: Affordable or free gyms all over Switzerland
* Family-friendly: Financial contributions to childcare
About us
Ypsomed Company Movie EN.
We are a successful, rapidly growing, family-owned company headquartered in Burgdorf (CH) with various production sites and subsidiaries around the world. With our market-leading products and solutions, we enable people all over the globe to self-treat. Despite chronic diseases such as diabetes, obesity, or certain types of cancer, they are provided with the greatest possible quality of life.