iSTAR Medical SA, founded in 2011 and headquartered in Wavre, Belgium, is an EU and Australia commercial stage, medical technology company focused on the development of MINIject, a novel minimally-invasive ophthalmic implant (MIGS) for patients with glaucoma. MINIject is an investigational device in the US, and commercially available OUS since 2021.

We are currently expanding our US team and looking to hire a Clinical Operations Specialist.

The Clinical Operations Specialist is a US field based role responsible for the implementation of iSTAR’s STAR-V [pronounced ‘STAR-Five’] IDE trial. The Clinical Operations Specialist will be supporting approximately 15 study sites in their efforts to identify, enroll and treat subjects eligible for the STAR-V trial. The position reports to the VP of Clinical Research.

The ideal candidate is a ‘success catalyser’ of trial enrolment: In close collaboration with all stakeholders in and around the clinical trial sites, he/she successfully identifies and overcomes challenges to meeting the STAR V enrolment objectives. The candidate will succeed in motivating and enabling trial sites to meet and beat enrolment goals, leading to FDA approval of MINIject as a stand-alone MIGS treatment for mild-moderate glaucoma patients in the US.

The candidate is a team-player and creative problem-solver, with a hands-on, can-do attitude. Strong interpersonal and communication skills and willingness to travel 60%-80% domestically are a must.

Prior experience in eye surgery and the MIGS space in commercial or clinical operations-related functions are preferred.

What will make you successful at iSTAR?

Effectively support patient enrolment into the STAR-V trial

Ensure sites meet enrolment goals in STAR V with a strong hands-on, field-based (60-80% travel), customer-centric approach.
Support site-specific communication efforts on STAR-V: Referral trainings, community outreach, patient information materials, on-site training.
Provide expert advice and best practice know-how to clinical research stake holders (Study coordinators, PI’s, techs, referrers etc) on patient selection.
Provide support to ensure flawless execution of all aspects of the clinical trial in the entrusted study sites, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), and Food and Drug Administration (FDA) regulations.

Provide procedure training and support implementations in the OR

Ensure site readiness for MINIject implantation in study patients
Conduct drylab training ahead of MINIject implantations
Successfully provide surgical training and case support for MINIject implantations in the STAR-V trial

Effective team-player

Work closely with peers in the STAR-V team to ensure collective success in reaching the trial’s enrolment objectives.
Collaborate within the iSTAR Matrix structure with regulatory affairs, R&D, Finance, Legal, supply chain etc. to ensure smooth, compliant and timely implementation of all aspects of the STAR-V clinical trial.
Build strong relationships with the local CRO partner (monitor).
Embrace iSTAR’s company values. Uphold the highest standards of ethics and quality at all times.

You are the future Clinical Operations Specialist, if you have….

At least 3 years of experience in a field-based commercial or clinical operations function related to ophthalmology, preferably glaucoma-related and ideally surgery-related
A degree in Ophthalmology, Optometry or equivalent experience-based qualification in the field
An action-oriented attitude with high energy drive for result-oriented actions
A personality motivated by autonomy and an intense, varied work environment including frequent domestic travel with up to 2-3 nights stay in a week.
A desire to learn, you are stress resistant and ready to work independently in a start-up environment (hands on).
An additional 2 years of demonstrated clinical operations experience with medical devices requiring surgical proctoring and OR support is a strong plus

Join us today!

We offer a full-time, open-ended contractor position along with an attractive remuneration package 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 team (engineers, scientists, as well as business and medical professionals) of innovative leaders with proven tracks 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.