What are the responsibilities and job description for the Clinical Research Associate Manager position at Spyglass Pharma?
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 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 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” doesn’t 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 top-tier 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 field-based 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, execution, 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 field-based CRAs, fostering professional development and high-performance standards.
- Oversee site selection, initiation, monitoring, and close-out 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 cross-functional 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 site-related 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 up-to-date knowledge of GCP, FDA regulations, and industry best practices to ensure compliance.
Qualifications Required For Position:
- Bachelor's degree in life sciences or a related field 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 field-based CRAs.
- 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 cross-functional teams and external partners.
- Strong organizational and problem-solving skills with keen attention to detail.
- Ability to travel up to 30-50% 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 $150,000 - $175,000, 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.
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 JOBS@SPYGLASSPHARMA.COM and let us know the nature of your request and your contact information.
Salary : $150