Clinical Site Lead (Medical Devices)
Employment Type: Full‑Time Equivalent (40 hours per week)
Start Date: As soon as possible, ideally no later than 1 November 2025
About the Role
We are seeking an experienced Clinical Site Lead to support our ongoing Structural Heart studies. This role will focus on clinical monitoring and data cleaning activities, ensuring the highest standards of quality, compliance, and patient safety across all assigned sites. The successful candidate will play a key role in the operational execution of medical device clinical studies within Switzerland.
Key Responsibilities
* Serve as the primary site contact for all operational and monitoring activities within assigned clinical studies.
* Perform on‑site and remote monitoring visits in accordance with study protocols, GCP, ISO 14155, and applicable regulatory requirements.
* Oversee and support data cleaning, source data verification, and query resolution activities to ensure data integrity and accuracy.
* Collaborate closely with cross‑functional teams (e.g., Clinical Project Management, Data Management, Regulatory Affairs) to ensure timely and compliant study execution.
* Train and support site personnel on study procedures, device handling, and documentation standards.
* Manage site performance metrics, identify risks or issues, and implement corrective and preventive actions.
* Contribute to monitoring plans, risk assessments, and study documentation as required.
* Participate in audits and inspections, ensuring site readiness and adherence to all clinical and regulatory standards.
Qualifications & Experience
* Bachelor’s or Master’s degree in Life Sciences, Nursing, Pharmacy, Biomedical Engineering, or a related field.
* Minimum of 5 years’ experience in clinical monitoring, with at least 3 years in medical device studies (Structural Heart or other implantable devices preferred).
* Strong understanding of GCP, ISO 14155, and relevant Swiss and EU clinical research regulations.
* Proven track record in data review, cleaning, and query management.
* Experience in study start‑up, monitoring, and site management within a regulated environment.
* Excellent organizational, communication, and stakeholder management skills.
* Ability to work independently and collaboratively within a cross‑functional, international environment.
Languages
* German (fluent) – mandatory
Why Join
This is an exciting opportunity to work with a global leader in innovative medical device research and to contribute directly to cutting‑edge Structural Heart therapies that improve patients’ lives. You will work in a highly collaborative, quality‑driven environment with opportunities for continued professional development.
Location: Bern, Berne, Switzerland.
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