About RetiSpec

RetiSpec is a Toronto-based medical AI company that aims to enable widespread early and accurate detection of neurodegenerative disease markers through a simple eye exam. RetiSpec's AI solutions leverage existing retinal imaging cameras available in most eye clinics to provide real-time results at the point of care, this means that the experience is familiar and comfortable. RetiSpec's AI solutions are currently available for Research Use Only.

The Opportunity

We are looking for a Clinical Study Lead to join our Clinical Operations team. This is not a purely oversight role, it is a position for someone who brings strategic experience and the confidence to shape how things are done, while also being genuinely comfortable rolling up their sleeves in a lean, fast-moving startup environment.

You will collaborate closely with our Clinical Operations Manager, assuming responsibility for key study execution activities across an active multi-study portfolio, while also contributing to higher-level work, including pivotal trial initiation, vendor and infrastructure assessment, and process standardization. As the team expands, there will be a clear opportunity to mentor new team members and contribute to the establishment of the clinical operations function from the outset.

This is an ideal role for someone who is energized by variety, thrives with ownership, wants to make a meaningful impact, and is happy to join us in-person in the Toronto office with some hybrid work structure options.

Responsibilities and Accountabilities

• Lead end-to-end clinical trial execution across a multi-site portfolio, ensuring compliance with applicable regulatory standards and GCP requirements
• Serve as the primary point of contact between clinical research sites and internal stakeholders, driving study performance and operational alignment
• Oversee clinical monitoring, data quality management, and inspection-ready documentation across all active studies
• Lead site initiation, operator training, and SOP development to standardise and scale clinical operations
• Manage study budgets, enrollment reporting, and clinical documentation using EDC, eTMF, and CTMS platforms
• Lead site activation and equipment deployment coordination, working cross-functionally with R&D, regulatory, and operations teams

Qualifications

• Bachelor's degree in life sciences, health sciences, science-related discipline, or equivalent
• Minimum 6 years of hands-on experience in clinical research, preferably in a sponsor-side role; experience at a research site, hospital, or CRO is also welcomed
• Current GCP certification (ICH E6 R2/R3) and TCPS2 is required
• Prior experience in data review meetings, query reconciliation, and database lock activities (final data cleaning, lock checklist completion, internal approval workflows)
• Proficient with EDC systems (e.g., Medrio, REDCap, Castor, Viedoc, or similar); ability to navigate, extract, and verify data including user roles, permissions, and data workflows
• Valid driver's licence and passport; ability and willingness to travel domestically and internationally as required

Skills

• Excellent written and verbal communication skills with the ability to exercise sound judgment, discretion, and initiative, including when handling confidential information, identifying obstacles and implementing effective solutions
• Strong organisational skills and exceptional attention to detail, especially in documentation, reporting, and communication with sites
• Demonstrated ability to multitask across multiple projects and teams, working independently in a fast-paced, highly interactive environment with minimal structure and shifting priorities
• Proficient in Microsoft Office / Google Workspace

Nice to Have

• Prior exposure to ophthalmology, neurology, cognitive disorders, Alzheimer's disease, or medical device / diagnostic imaging trials
• Certification strongly preferred: CCRP/ACRP or actively pursuing
• Experience with JIRA or similar project management / issue-tracking tools

Salary range: $82K to $98K per annum. Individual compensation is based on experience, education, and job-related factors.

RetiSpec is committed to fostering an inclusive, barrier-free, and accessible environment. Part of this commitment includes arranging accommodations to ensure an equitable opportunity to participate in the recruitment and selection process. If you require any accommodations during the application or interview process, please let us know and we will work with you to meet your needs.