Job Title:
Clinical Site Lead (Medical Devices)
Location:
Bern, Switzerland (Hybrid / Field-Based)
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
* English (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.