Summary:
The Clinical Study Manager (CSM) plays a key role in the planning and execution of SpyGlass Pharma's 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 8-10 years of clinical research or clinical study management experience within the pharmaceutical, biotech, or medical device industry.
- Bachelor's 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 $140,000 - $160,000, based on experience and qualifications, along with an Annual Bonus opportunity.
- Share in our success with stock options, giving you a stake in the company's 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.
