Senior Clinical Research Specialist
vor 2 Wochen
About the Role
We are seeking a highly skilled and experienced Senior Clinical Research Specialist to join our team at Ypsomed.
As a Senior Clinical Research Specialist, you will be responsible for overseeing global clinical trials, ensuring compliance with ISO standards, the Declaration of Helsinki, and relevant national laws and regulations.
- Responsible for overseeing global clinical trials, ensuring compliance with ISO standards, the Declaration of Helsinki, and relevant national laws and regulations.
- Ensure adherence 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 in compliance with GCP guidelines and internal quality standards.
- Plan, coordinate, and conduct audits at CROs and trial sites to ensure compliance with GCP guidelines, internal quality standards, study protocols, and regulatory requirements.
- Establish and maintain constructive relationships with local and 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.
- 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 to ensure compliance with study standards and guidelines.
- Provide medical-scientific support for the internal R&D, Marketing & Sales departments.
- Write Clinical Development Plans, Clinical Evaluation Plans, and Reports, as well as Post-Market Clinical Follow-Up Plans and Reports for new products and indications.
About You
We are looking for a highly skilled and experienced Senior Clinical Research Specialist with a Master of Science (MSc) degree in a natural science discipline or in the health sector, or equivalent qualification.
- 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 the 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.
- Any other language is an advantage.
About Ypsomed
Ypsomed is a successful, rapidly growing, family-owned company headquartered in Burgdorf (CH) with various production sites and subsidiaries around the world.
We develop and produce injection and infusion systems for self-medication with the Ypsomed Group.
We enable people all over the globe to self-treat chronic diseases such as diabetes, obesity, or certain types of cancer with the greatest possible quality of life.
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