Clinical Study Manager

About SpyGlass Pharma:

At SpyGlass Pharma (NASDAQ: SGP) we are focused on improving and preserving the vision of patients suffering from chronic eye conditions while minimizing the impact on their daily lives. We aim to achieve this by developing cutting-edge long-term drug delivery products to address common causes of blindness and getting these products to the patients that need them.

We have built a highly collaborative team with deep expertise across ophthalmology drug delivery pharmaceuticals and medical devices. Our scientists engineers and clinical leaders bring decades of experience developing and commercializing breakthrough technologies united by a shared commitment to patients and our guiding principle: We create for patients. That mindset shapes how we build our products our teams and our culture.

Backed by strong clinical progress significant funding and a growing organization SpyGlass Pharma is entering an exciting stage of growth as we advance our lead program the SpyGlass BIM-IOL through Phase 3 clinical development.

Summary:

The Clinical Study Manager (CSM) plays a key role in the planning and execution of SpyGlass Pharmas clinical trials. Working closely with the Director of Clinical Research and cross-functional teams the CSM is responsible for managing day-to-day study operations to ensure clinical studies are conducted efficiently compliantly and on schedule. This role supports protocol development vendor and site coordination study oversight and clinical documentation across the lifecycle of a study.

The ideal candidate brings experience managing clinical studies within the pharmaceutical biotech or medical device industry and is comfortable operating in a fast-paced collaborative environment. As SpyGlass advances its clinical programs toward pivotal milestones the CSM will help ensure studies are executed with rigor organization and strong cross-functional coordination.

Essential Duties and Responsibilities:

• Manage day-to-day clinical study activities including timelines study documentation vendor coordination and site communications.
• Support the planning and execution of clinical studies in collaboration with the Director of Clinical Research and cross-functional teams.
• Contribute to the development and review of clinical study documents including protocols investigator brochures study reports and clinical sections of regulatory submissions.
• Ensure clinical trials are conducted in accordance with applicable regulatory requirements ICH-GCP guidelines and internal procedures.
• Monitor study progress and key milestones identifying risks or operational challenges and working with the team to implement solutions.
• Coordinate cross-functional activities with Clinical Operations Regulatory Affairs R&D Quality and external vendors to ensure smooth study execution.
• Support preparation for regulatory interactions study updates and clinical documentation required for submissions and annual reports.
• Maintain oversight of study timelines budgets and deliverables to ensure studies are completed on schedule and within scope.
  

Qualifications Required for Position:

• Approximately 810 years of clinical research or clinical study management experience within the pharmaceutical biotech or medical device industry.
• Bachelors degree in a life sciences or related field preferred.
• Experience supporting or managing clinical trials including protocol execution site oversight vendor coordination and study documentation.
• Strong understanding of clinical trial regulations including ICH-GCP and applicable FDA and international regulatory guidelines.
• Experience supporting regulatory submissions such as INDs IDEs amendments or annual reports preferred.
• Ability to work effectively in a cross-functional matrixed environment while managing multiple study priorities.
• Strong organizational communication and problem-solving skills with attention to detail.
  

Why SpyGlass Pharma

• We are offering a range of $140000 - $160000 based on experience and qualifications along with an Annual Bonus opportunity.
• Share in our success with stock options giving you a stake in the companys future.
• Comprehensive health dental and vision insurance plans to keep you and your family healthy and happy with a variety of plan and coverage options.
• Generous paid time off including holidays vacation days and personal leave.
  

SpyGlass Pharma is an Equal Opportunity Employer and participates in E-Verify. SpyGlass Pharma takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion gender national origin age sexual orientation gender identity marital or veteran status disability or any other legally protected status.

SpyGlass Pharma is also committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please send an email to and let us know the nature of your request and your contact information.

Required Experience:

Manager