Job Summary Table of Clinical Trial Lead

Job Description Summary

The Clinical Trial Lead will manage international clinical studies for iSTAR Medical’s groundbreaking glaucoma treatment products, overseeing trials from initiation to completion while ensuring compliance with regulatory standards and coordinating with cross-functional teams to meet project deliverables within budget and timelines.

Clinical Trial Management Responsibilities 🔍

• Oversee and manage international clinical trials from initiation to completion, ensuring adherence to budget constraints and project timelines
• Coordinate effectively with cross-functional teams to achieve project milestones and ensure all deliverables are met on schedule
• Develop, monitor, and report on key performance indicators (KPIs) and project progress, including detailed timelines, budgets, and deliverables
• Manage selection, contract negotiation, relationship development, and performance evaluation of CROs/Service Providers while implementing comprehensive oversight plans
• Review and develop study-specific documents including protocols, patient informed consent forms, monitoring plans, oversight plans, manuals of operations, and clinical study reports
• Support the trial site selection process by evaluating potential sites and conducting thorough due diligence assessments
• Coordinate submissions to Competent Authorities and Ethical Committees in collaboration with the Regulatory Affairs department, including document development, tracking submission timelines, and addressing inquiries
• Facilitate trial activities such as contract negotiation, site initiation, and training of CROs and clinical sites
• Coordinate and oversee monitoring activities including site visits, remote monitoring, site management, and collection of essential documents

Technical and Operational Responsibilities 📊

• Collaborate with CROs on e-CRF design and database development to ensure optimal data collection
• Review and approve payments to CROs, service providers, hospitals, and investigators in accordance with contractual agreements
• Oversee the development and maintenance of the Trial Master File, both internally and in conjunction with CROs
• Identify and mitigate potential risks to the project through proactive risk management strategies
• Identify and report quality and non-compliance issues, manage the CAPA process with the Quality department, and ensure implementation of corrective actions
• Ensure all study conduct adheres to ICH-GCP, ISO 14155, and other applicable regulations and guidelines

Qualifications and Experience Requirements 📝

The ideal candidate for this role should possess a combination of educational qualifications, professional experience, and personal attributes that will enable them to excel in managing complex clinical trials in the ophthalmic field.

Educational Background

• Bachelor’s degree in Life Sciences or related field with a minimum of 5 years of related clinical trial management experience, OR
• Master’s degree in Life Sciences or related field with relevant experience in clinical research

Professional Experience

• Minimum of 3 years of demonstrated experience specifically in managing global, multi-center ophthalmic clinical trials
• Strong track record in managing EU and U.S. FDA-regulated clinical trials
• Experience in ophthalmology clinical trial management is required, with medical device experience strongly preferred
• In-depth knowledge of clinical trial processes, Good Clinical Practice (GCP), and clinical trial regulations and guidelines

Skills and Attributes

• Fluent communication skills (both oral and written) in English
• Proven track record of successfully managing complex projects with multiple stakeholders
• Recognized leadership and project management capabilities in clinical settings
• Effective communication skills with the ability to set priorities and demonstrate strong time management
• Team-oriented approach with a positive, constructive attitude toward problem-solving
• Capability to manage multiple projects simultaneously without compromising quality
• Detail-oriented mindset with exceptional organizational skills
• Strong problem-solving abilities and decisive decision-making capabilities
• Ability to work effectively under pressure and meet tight deadlines
• Willingness and availability to travel internationally up to 20% of the time

Benefits and Perks 🌟

• Competitive remuneration package commensurate with experience and expertise
• Unique opportunity to join an innovative startup with significant growth potential in the MIGS market
• Collaboration with a highly skilled management team with proven industry expertise
• Work alongside a dynamic team of innovative professionals including engineers and scientists
• Career development opportunities within a rapidly growing organization
• Participation in groundbreaking medical advancements that improve patient outcomes

Company Overview 🏢

iSTAR Medical is dedicated to delivering breakthrough eye care solutions that transform patient outcomes. Our most advanced product, MINIject®, has received European approval for the treatment of open-angle glaucoma – the leading cause of irreversible blindness globally. The company is currently working toward seeking market approval in the United States, expanding our global reach.

We believe that MINIject’s distinctive tissue-integrating capabilities provide a safer and more effective treatment option for patients suffering from glaucoma. Our mission extends beyond MINIject® as we build an exceptional portfolio of potentially leading products to establish new treatment paradigms in eye care conditions with the highest patient needs.

Company Culture 🌱

At iSTAR Medical, we foster an agile startup company culture focused on core values that drive our success:

• Entrepreneurship: We encourage innovative thinking and proactive problem-solving
• Engagement: We promote active participation and dedication to our shared mission
• Integrity: We uphold the highest ethical standards in all our operations
• Passion: We are deeply committed to improving patient outcomes through innovation
• Excellence: We strive for exceptional quality in all aspects of our work

Our work environment is characterized by collaboration, innovation, and a shared commitment to advancing medical solutions that make a meaningful difference in patients’ lives.

Career Growth Opportunities 📈

As a Clinical Trial Lead at iSTAR Medical, you’ll have the opportunity to:

• Play a pivotal role in bringing revolutionary medical devices to market
• Expand your expertise in ophthalmology and clinical research
• Develop leadership skills through managing complex, international projects
• Build a global professional network within the medical device and ophthalmology sectors
• Contribute to the growth of a promising startup with significant market potential
• Participate in cutting-edge research that advances the field of glaucoma treatment

Diversity, Equity, Inclusion, and Belonging 🌍

iSTAR Medical is committed to creating an inclusive workplace where diverse perspectives are valued and respected. We believe that innovation thrives in environments where different backgrounds, experiences, and viewpoints contribute to creative problem-solving and scientific advancement.

Equal Opportunity Statement ⚖️

iSTAR Medical is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic.

Remote Work Policy 🏠

This position operates on a hybrid model with the expectation of international travel (up to 20% of working time). The role involves both on-site presence and remote work capabilities, with specific arrangements to be discussed during the hiring process.

Application Process 📋

1. Submit your application through the provided LinkedIn link
2. Qualified candidates will be contacted for an initial screening interview
3. Successful candidates will proceed to technical and team interviews
4. Final candidates may be asked to complete a role-specific assessment
5. References will be checked before extending an offer

How to Apply 📨

Interested candidates should apply through the LinkedIn job posting link provided below. Please include a comprehensive CV highlighting your experience in clinical trial management, particularly in the ophthalmology field.

Apply on LinkedIn

For more information about iSTAR Medical, please visit: www.istar-medical.com

Explore Blog Articles:

1. UK Skilled Worker Visa – Complete Guide
2. Sweden Job Seeker Visa – How to Apply
3. Portugal’s Job Seeker Visa – What You Need to Know
4. Germany EU Blue Card – Benefits and Requirements