Senior Clinical Trial Manager
Solliciteren
Plaats
Wavre1300
Waals-Brabant
België
Contract
Vooltijds, Onbepaalde duurDatum gepubliceerd
2026-02-17Online to:
2026-04-18EUR 20.00 HOUR
Senior Clinical Trial Manager
- iSTAR Medical
- Waals-Brabant
- 3 dagen geleden
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:
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
Lead end‑to‑end management of international ophthalmology trials (FIH, pivotal, PMCF).
Oversee CROs, vendors, and EU investigational sites to ensure quality, compliance, and patient safety.
Develop protocols, manage timelines/budgets, and ensure inspection‑ready documentation.
Support regulatory submissions, CERs, PMCF activities, and cross‑functional evidence development.
Collaborate with R&D, Medical Affairs, Quality, and Regulatory teams to support new product launches and market expansion.
What You Bring
Master's degree in Life Sciences or related field.
7–10+ years in clinical research, with strong experience in medical device (ophthalmology trials ideally).
Proven leadership in multinational EU studies and deep knowledge of ISO 14155 and EU MDR.
Excellent communication skills; English required (French a plus).
What 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 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
Lead end‑to‑end management of international ophthalmology trials (FIH, pivotal, PMCF).
Oversee CROs, vendors, and EU investigational sites to ensure quality, compliance, and patient safety.
Develop protocols, manage timelines/budgets, and ensure inspection‑ready documentation.
Support regulatory submissions, CERs, PMCF activities, and cross‑functional evidence development.
Collaborate with R&D, Medical Affairs, Quality, and Regulatory teams to support new product launches and market expansion.
What You Bring
Master's degree in Life Sciences or related field.
7–10+ years in clinical research, with strong experience in medical device (ophthalmology trials ideally).
Proven leadership in multinational EU studies and deep knowledge of ISO 14155 and EU MDR.
Excellent communication skills; English required (French a plus).
What 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.
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