Clinical Research Manager
Vor 6 Tagen
We are seeking a highly skilled Clinical Research Manager to join our team at Ypsomed. As a key member of our clinical development team, you will be responsible for overseeing global clinical trials, ensuring compliance with regulatory requirements, and collaborating with medical experts and external advisors.
Key Responsibilities- Oversee global clinical trials, ensuring compliance with ISO, the Declaration of Helsinki, and relevant national laws and regulations.
- Adhere to budgets, timelines, milestones, and task completion of clinical trials.
- Supervise and support CROs and trial centers in the preparation and conduct of clinical studies.
- Plan, coordinate, and conduct audits according to predefined audit plans and checklists at CROs and trial sites.
- Establish and maintain constructive relationships with local and international opinion leaders, trial centers, CROs, and other third parties.
- Communicate effectively with internal and external stakeholders, including regulatory authorities, ethics committees, CROs, investigators, and advisors.
- Contribute to the scientific evaluation and interpretation of study results, including the preparation of reports and publications.
- Organize and implement training measures for Ypsomed employees and study team members.
- Provide medical-scientific support for internal R&D, Marketing & Sales departments.
- Develop Clinical Development Plans, Clinical Evaluation Plans, and Reports for new products and indications.
- 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.
- Fluent in written and spoken English.
- Any other language is an advantage.
- 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.
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