iSTAR Medical is committed to delivering breakthrough eye care solutions. Our most advanced product, MINIject®, is approved in Europe for the treatment of open-angle glaucoma – the leading cause of irreversible blindness – and we are aiming to seek market approval in the US. We believe MINIject’s distinctive tissue-integrating capabilities unlock a safer, and more effective option for patients. We are building an exceptional team and pipeline of potentially leading products such as MINIject® to establish new treatment paradigms in eye care conditions with the highest patient needs. For more information, please visit: www.istar-medical.com
We are a science‑driven, agile, and collaborative company committed to generating high‑quality clinical evidence that meets the evolving requirements of EU Medical Device Regulation (MDR), we are looking for a Senior Clinical Trial Manager to lead our multinational clinical programs.
As Senior Clinical Trial Manager, you will own the strategic and operational leadership of our ophthalmology clinical investigations across Europe and global markets. You will ensure trials are designed and executed according to ISO 14155, EU MDR, and international regulatory standards—while shaping the evidence strategy that supports new market access and product innovation.
Key Responsibilities
Strategic & Clinical Leadership
Develop and implement clinical evidence strategies for EU and global expansion.
Lead full lifecycle management of international trials (FIH, pivotal, PMCF).
Guide protocol development and ophthalmic endpoint selection.
Manage study budgets, timelines, and resources across multiple countries.
Operational Excellence
Select, negotiate with, and manage CROs, vendors, and EU investigational sites.
Oversee monitoring activities to ensure data integrity and patient safety.
Lead investigator meetings, site training, and cross‑border study communications.
Anticipate operational risks and ensure full compliance.
Regulatory & Quality Compliance
Ensure adherence to ISO 14155, EU MDR 2017/745, ICH‑GCP, and local EU requirements.
Support submissions, substantial modifications, and responses to EU authorities.
Participate in Notified Body audits and internal QA reviews.
Cross‑Functional Collaboration
Partner with Clinical Science, R&D, Medical Affairs, Quality, and Regulatory teams.
Contribute to CERs, PMCF plans, risk management files, and launch‑ready evidence.
Support publications, scientific communications, and congress activities.
Provide clinical insights to marketing, product development, and market access.
Documentation & Reporting
Oversee clinical reports, narratives, safety documents, and regulatory deliverables.
Analyze study data and present insights to leadership.
Ensure complete and inspection‑ready TMFs.
Qualifications
Required
Master’s degree (Life Sciences, Biomedical Engineering, Optometry/Ophthalmology, or related).
7+ years of clinical research experience, including medical device trials.
Strong track record managing multinational European clinical trials.
Deep understanding of EU MDR, ISO 14155, and European authority processes.
Excellent leadership, communication, and vendor management skills.
Fluency in English.
Proven experience in ophthalmology (glaucoma, cataract, refractive surgery, etc.) ideally
Preferred
Experience in a MedTech scale‑up operating across multiple EU markets.
Good level of French
Offer
We offer a full-time permanent position along with attractive remuneration packages and the unique opportunity to join a start-up with the potential to become a future key player in MIGS market today.
Headed by a solid management team, you will be part of a highly skilled (engineers, scientists) capable and dynamic team of innovative leaders with proven track records in the pharmaceutical and medical device industries.
We have an agile start-up company culture focused on values of entrepreneurship, engagement, integrity, passion and excellence.
!! Any unsolicited CVs submitted by agencies will be treated as direct applications and will not be subject to agency fees.