Job Description

Job Description

Job Description

Salary: $130k - $140k

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.

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SUMMARY:

The Principal Clinical Data Manager will play a key role in managing and overseeing data management activities across clinical studies. This individual will work collaboratively with cross-functional teams, ensuring data integrity and compliance with regulatory standards. The Principal, Clinical Data Manager, will provide oversight for the design, collection, and analysis of clinical data, working closely with clinical operations, biostatistics, and external vendors.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Lead data management activities for clinical trials, including protocol review, CRF design, database design, data cleaning, and database lock.
• Collaborate with clinical teams to ensure data management deliverables meet timelines, budget, and regulatory compliance.
• Oversee the development of data management plans (DMPs), data review guidelines (DRGs), and data quality control processes.
• Manage vendor selection and oversight for electronic data capture (EDC) systems and other data management tools.
• Ensure compliance with FDA, EMA, ICH-GCP, and company SOPs for clinical data management.
• Provide data management expertise to cross-functional study teams, ensuring accurate and complete data for clinical study reports (CSR) and regulatory submissions.
• Collaborate with Biostatistics, Clinical Affairs, and Regulatory teams to resolve data discrepancies and perform quality checks.
• Train and mentor junior data management staff.
• Support audit and inspection activities related to data management.
  

QUALIFICATIONS REQUIRED FOR POSITION:

• Bachelor's degree preferred.
• Minimum of 8 years of experience in clinical data management, including experience with ophthalmology or drug-device combination products.
• Expertise in EDC systems (e.g., iMedNet, Medidata RAVE, Oracle InForm) and other data management tools.
• Strong understanding of CDISC standards (SDTM, ADaM).
• Knowledge of FDA, EMA, and ICH-GCP regulatory requirements and industry best practices in clinical data management.
• Proven experience managing data for Phase I-IV clinical trials.
• Excellent project management skills and ability to manage multiple studies.
• Strong communication and leadership skills to work effectively with cross-functional teams.
• Experience working in a fast-paced environment, managing third-party vendors, and ensuring high-quality data deliverables.

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 [email protected] and let us know the nature of your request and your contact information.

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