Clinical Research Associate Manager

About SpyGlass Pharma:

At SpyGlass Pharma 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 cuttingedge longterm drug delivery products to address common causes of blindness and getting these products to the patients that need them.

We have built a team of driven professionals with diverse expertise in ophthalmic products and drug delivery. Our accomplished scientists and engineers work alongside a seasoned leadership team with extensive experience in ophthalmology and a history of commercial success. Our unifying mantra We create for patients doesnt just live on our walls but drives our decision making as we build the company creating the products processes and culture that make it happen.

This team has delivered a solid foundation of development and clinical data enabling over $120 million in funding to date with several toptier venture partners. We are building confidence in the performance of our lead product going into Phase 3 clinical trials.

Summary:

We are seeking a Clinical Research Associate (CRA) Manager to join our team at SpyGlass Pharma. The CRA Manager is responsible for leading and managing a team of fieldbased Clinical Research Associates who monitor clinical trials at investigative sites. This position ensures that clinical trials are conducted in compliance with study protocols Good Clinical Practice (GCP) FDA regulations and applicable standard operating procedures (SOPs). The CRA Manager will oversee the planning and management of site monitoring activities to ensure data integrity and patient safety.

Essential Duties & Responsibilities:

• Manage mentor and provide leadership to a team of fieldbased CRAs fostering professional development and highperformance standards.
• Oversee site selection initiation monitoring and closeout visits to ensure compliance with study protocols and regulatory requirements.
• Develop and implement monitoring plans and strategies to optimize site performance and data quality.
• Collaborate with crossfunctional teams including Clinical Operations Data Management and Regulatory Affairs to support clinical trial objectives.
• Ensure that CRAs are adequately trained on study protocols SOPs and regulatory requirements.
• Review monitoring reports and provide feedback to CRAs to ensure consistency and adherence to monitoring standards.
• Identify and resolve siterelated issues and escalate as appropriate to senior management.
• Participate in the development and review of study documents including protocols case report forms and informed consent forms.
• Contribute to the development and improvement of departmental processes and SOPs.
• Maintain uptodate knowledge of GCP FDA regulations and industry best practices to ensure compliance.
  

Qualifications Required For Position:

• Bachelors degree in life sciences healthcare or a related field; advanced degree preferred.
• 10 years of clinical research experience in the pharmaceutical or medical device industry with at least 2 years in a supervisory or managerial role overseeing fieldbased CRAs. A commensurate combination of education and experience will be considered.
• Strong knowledge of clinical trial monitoring practices GCP FDA regulations and clinical trial management systems.
• Proven ability to lead mentor and develop a team of clinical professionals.
• Excellent verbal and written communication skills with the ability to interact effectively with crossfunctional teams and external partners.
• Strong organizational and problemsolving skills with keen attention to detail.
• Ability to travel up to 3050 domestically as required.
• Proficiency in Microsoft Office Suite and experience with electronic data capture (EDC) systems.
  

Why SpyGlass Pharma

• We are offering a range of $150000 $175000 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 EVerify. 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