Clinical Research Specialist
Vor 4 Tagen
The successful candidate will have the opportunity to work in a dynamic and rapidly growing company, Ypsomed, which develops and produces injection and infusion systems for self-medication.
As a Clinical Research Specialist - Medical Devices, you will be 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 Articles through and Annex XV of EU Regulation 7/ (MDR), as well as adhering to clinical trial standards as governed by the Food and Drug Administration (FDA).
You will be responsible for budget management, timeline coordination, and milestone completion of clinical trials, supervising and supporting Contract Research Organizations (CROs) and trial centers in preparation and conduct of clinical studies in close collaboration with medical experts and external advisors.
Your role will also involve 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.
In addition, you will establish and maintain constructive relationships with local and international opinion leaders, trial centers, CROs, and other third parties, providing effective communication with internal and external stakeholders including regulatory authorities, ethics committees, CROs, investigators, and advisors.
Contribution to scientific evaluation and interpretation of study results, including preparation of reports and publications, is also an essential part of this role.
Furthermore, you will be responsible for 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 the internal R&D, Marketing & Sales departments is also required.
You will write Clinical Development Plans/Clinical Evaluation Plans and Reports, Post-Market Clinical Follow-Up Plans (and Reports) for new products and new indications.
The estimated salary for this position is around CHF 90,000 per year, depending on experience and qualifications.
We are looking for candidates with a Master's degree in a natural science discipline or health sector, or equivalent qualification. A Doctorate (PhD or Dr.) is an advantage.
A minimum of two years of experience in planning and monitoring clinical trials is required, along with 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 and strong scientific understanding, particularly in the field of medical devices (at least Class II), are necessary.
Fluent written and spoken English is required; any additional languages are an advantage.
This position offers various benefits, including shiftwork, annual working hours, part-time arrangements, FlexWork options, up-to-date production facilities, offices, break areas, pension fund contributions, mobility support, free sport facilities, financial contributions to childcare, and more.
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