Senior Clinical Trial Associate
2 weeks ago
About SpyGlass Pharma:
At SpyGlass Pharma, we are actively engaged in projects addressing unmet needs in glaucoma and cataract surgery/intraocular lens replacement, striving for paradigm shifts in global eye care.
Our team comprises professionals with diverse expertise in ophthalmic devices and drug delivery. Our accomplished scientists and engineers work alongside a seasoned leadership team with extensive experience in ophthalmology, IOL development, and commercial success. Led by a proven team with expertise in science, R&D, communications, and operations, SpyGlass Pharma™ takes ideas from inception through commercialization.
Our commitment to actively improving patients’ quality of life drives the company to innovate and succeed.
Learn more at www.spyglasspharma.com
SUMMARY:
We are seeking a Clinical Trial Associate/ Senior CTA, Senior CTA2, Principal CTA (CTA) of Clinical Affairs to join our team at SpyGlass Pharma. The CTA is responsible for executing the tasks on the clinical team throughout the clinical trial. This position has the responsibility for supporting the Manager, Clinical Operations in executing and implementing global clinical decisions. This includes responsibility for the clinical team’s creation of relevant documents and outputs including feasibility questionnaires, regulatory documents, enrollment reports, data listings, and patient summaries. The CTA will review the investigator brochures, study protocol synopsis, clinical study protocols, top line study data, Clinical Study Report (CSR), clinical sections of regulatory documents and the Annual reports. This position executes, implements, and manages various tasks to assist in the achievement of all activities related to the Clinical development program, including achievement of key program milestones within the planned timelines and budget. The position may interact with multiple levels in the organization, participating in discussions with management and providing clinical updates.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Support the Clinical Affairs team to execute tasks throughout the clinical trials.
- Manage and execute the tasks for the strategic objectives defined by the project team
- Work with clinical team to execute global clinical strategies, programs, and protocols.
- Provide clinical support to interdisciplinary project teams, aligning with FDA/Regulatory Agency requirements, FDA/ICH guidelines, IRB/IEC requirements, Good Clinical Practices (GCP), and industry best practices.
- Be aware of clinical issues and help to resolve them.
- Participate in FDA, Regulatory Agency, IRB/IEC meetings as needed.
- Review of regulatory submissions, including clinical trial applications, IND, IDE, NDA, PMA, annual reports, CIB updates, meeting packages, technical files/design dossier for FDA and other regulatory agencies as needed.
- Facilitate regulatory document collection and follow-up with team members, ensuring that all documents and tasks are in accordance with predetermined timelines.
- Work in a dynamic, matrixed environment by collaborating closely with cross-functional teams, including R&D, Regulatory Affairs, Quality Assurance, and project management teams, while following GCP and industry best practices.
- Interact and coordinate with R&D staff (CMC and Engineering), vendors, and consultants to ensure compliance to applicable Design Control and pharmaceutical requirements (for drug/device combination products).
- Learn about clinical trends, changes, and requirements in the pharmaceutical industry, providing recommendations to senior management on regulatory matters.
QUALIFICATIONS REQUIRED FOR POSITION:
- Bachelor's degree preferred.
- Minimum of 4 years of experience in clinical affairs within the pharmaceutical or medical device industry, with a preference on drug and drug/device combination products.
- Some experience in a cross-functional development team/subteam in a clinical development organization
- Knowledge of GCP and industry best practices with clinical trial management, monitoring, regulatory compliance, data management and statistical reporting.
- Knowledge of US clinical and regulatory requirements and guidelines for drug and drug/device combination products, including FDA/Regulatory Agency requirements, FDA/ICH guidelines, and IRB/IEC requirements.
- Awareness of preparing US IND/amendments, annual reports, and briefing books.
- Awareness of preparing the annual budget forecast and monitor expenditures.
- Knowledge of the CFR, FDA/ICH guidelines, GxP and cGMP as they pertain to pharmaceutical development and manufacturing.
- Previous experience conducting clinical studies, meetings, enrollment, and interactions with regulatory agencies.
- Willingness to learn leadership, communication, and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external partners.
- Awareness of clinical strategy development, investigational product supply, regulatory compliance, and clinical activities for clinical trials of all phases.
- Ability to work in a fast-paced, dynamic environment and manage multiple projects simultaneously while maintaining attention to detail and quality.
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.
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