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

Reporting to the VP Clinical Affairs, the Clinical Trial Lead will manage one or several international clinical studies, dependent on size and complexity. The position will interact with internal stakeholders and CROs/vendors and manage the timeline, budget, and all project deliverables. 

Responsibilities

•          Oversee and manage clinical trials from initiation to completion within budget and project timelines.

•          Coordinate with cross-functional teams to ensure project milestones are achieved.

•          Develop, monitor and report on key performance indicators (KPIs) and project progress, including timelines, budgets, and deliverables.

•          Manage and ensure oversight of CROs/Service Providers (selection, negotiate/set-up contracts, relationships development, performance evaluation, oversight plans)

•          Review and/or develop specific study-related documents (protocol, patient informed consent, monitoring plan, oversight plan, manual of operations, clinical study report...)

•          Support process of Trial Site Selection (evaluation of sites, due diligence,...);

•          Coordinate submission to Competent Authorities and Ethical Committee (develop documents, track submission timelines, answer questions,...) with Regulatory Affairs department

•          Support Trial Activities (negotiate/set-up contracts, site initiation, training of CRO/clinical sites)

•          Coordinate and oversee Monitoring activities (monitoring visits, remote monitoring activities, site management, essential documents collection);

•          Coordinate e-CRF design and database development with CRO

•          Reviews and approves payments to CROs/Service providers, hospitals and investigators

•          Oversight of the Trial Master File (development and maintenance) internally and/or with the CRO

•          Identify and mitigate potential risks to the project.

•          Identify and report quality and non-compliance issues, manage CAPA process with Quality department and ensure implementation of corrective actions

•          Ensure study conduct is performed according to ICH -GCP, ISO 14155 and other applicable regulations

Profile

•            You own a Bachelor’s degree in Life Sciences or related field and a minimum of 5 years of related clinical trial management experience , or Master’s degree in Life Sciences or related field

•            You have a minimum of 3 years of demonstrated experience in managing global, multi-centre ophthalmic clinical trials;

•            Experience in ophthalmology clinical trial management required, with medical device experience preferred.

•            Strong track record with managing EU / U.S. FDA-regulated clinical trials.

•            In-depth knowledge of clinical trial processes, GCP, clinical trial regulations and guidelines.

•            Fluent communication skills (oral and written) in English

•            Proven track record of managing complex projects.

•            Recognised for your Leadership and Project Management capabilities;

•            Can communicate effectively; set priorities and you have strong time management skills;

•            Team player with positive constructive attitude to solve problems;

•            Ability to manage multiple projects simultaneously.

•            Detail-oriented with strong organizational skills.

•            Strong problem-solving and decision-making capabilities.

•            Ability to work under pressure and meet tight deadlines.

•            You are flexible to travel internationally up to 20% of your time

Offer

We offer a full-time 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.