About the Role:

We are seeking an experienced Clinical Trial Manager (CTM) with expertise in retinal diseases, particularly Geographic Atrophy (GA) or other retina-related indications, to lead and manage clinical trials within our ophthalmology program. The ideal candidate will have a deep understanding of the unique challenges and complexities in retina clinical trials, as well as a proven track record of successfully managing the execution of multi-center, global clinical trials. As a key member of the Clinical Operations team, you will oversee the entire lifecycle of clinical trials, from protocol development through study closeout.

Key Responsibilities:

• Clinical Trial Management:
• Lead the planning, execution, and oversight of clinical trials for Geographic Atrophy (GA) and other retinal diseases, ensuring adherence to timelines, budgets, and quality standards.
• Study Planning and Design:
• Collaborate with cross-functional teams (including Medical Affairs, Regulatory, Data Management, and Biostatistics) to develop trial protocols, study plans, and regulatory submission documents. Provide expertise in ophthalmology clinical endpoints, patient recruitment, and trial design.
• Site Management:
• Oversee site selection, training, and monitoring to ensure that clinical sites comply with the study protocol, Good Clinical Practice (GCP), and regulatory requirements. Act as the primary point of contact for clinical sites and ensure effective communication and issue resolution.
• Vendor Oversight:
• Manage relationships with external vendors (e.g., CROs, laboratories, imaging services) to ensure deliverables are met in accordance with contractual agreements, timelines, and quality standards.
• Data Integrity and Compliance:
• Monitor data collection and ensure the accuracy, completeness, and integrity of clinical trial data. Ensure compliance with all regulatory requirements, including ICH-GCP, FDA, and EMA guidelines.
• Risk Management:
• Proactively identify potential risks or issues impacting trial timelines, quality, or patient safety. Develop and implement risk mitigation strategies in collaboration with senior leadership.
• Team Leadership and Development:
• Provide guidance, mentorship, and support to junior clinical trial staff, ensuring team alignment and development throughout the course of the study.
• Reporting and Documentation:
• Prepare and review study reports, presentations, and other documents for internal and external stakeholders, including regulatory bodies, investors, and ethics committees.
• Continuous Improvement:
• Contribute to process improvements in clinical trial execution, and actively participate in post-study debriefs and lessons-learned activities to enhance future clinical trials.

Qualifications:

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related field; advanced degree (e.g., Master’s, PharmD, MD) is a plus.
• Minimum of 5+ years of experience managing clinical trials, with a strong focus on ophthalmology, particularly Geographic Atrophy (GA) or other retinal diseases is required.
• Demonstrated experience in managing global, multi-center clinical trials in Phases 1-3.
• In-depth knowledge of ophthalmology-specific clinical endpoints, biomarkers, and clinical trial design.
• Familiarity with the regulatory landscape for ophthalmic clinical trials (FDA, EMA, ICH-GCP).

Skills and Competencies:

• Strong project management skills, including budget management, timeline tracking, and resource allocation.
• Exceptional communication skills, with the ability to collaborate effectively across cross-functional teams and manage relationships with external vendors and clinical sites.
• Strong problem-solving skills and ability to manage multiple priorities in a fast-paced environment.
• Proficient with clinical trial management systems (CTMS), electronic data capture (EDC) platforms, and other industry-standard software.
• Certifications:
• Clinical Research Coordinator (CRC) or Clinical Research Associate (CRA) certification (e.g., ACRP, SOCRA) is a plus.
• Travel Requirements:
• Occasional travel (up to 20%) to clinical sites and meetings.