Glaukos Corporation

Manager Study Start-up

Glaukos Corporation  •  United States (Onsite)  •  2 hours ago
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Job Description

How You’ll Contribute:

Clinical Study Manager

The Clinical Study Manager is responsible for the end-to-end management and execution of clinical studies supporting medical device development. This role leads cross-functional teams to ensure studies are conducted in compliance with regulatory requirements, delivered on time and within budget, and aligned with Glaukos clinical and business objectives. The Clinical Study Manager serves as the central point of accountability for study delivery, overseeing operational execution, site performance, and data quality.

What You’ll Do:

• Lead the operational execution of clinical studies from start-up through close-out, including site initiation, enrollment, monitoring, and close-out activities.
• Develop and manage study timelines, milestones, and deliverables to ensure on-time and high-quality execution.
• Contribute to study design, including protocol development, case report forms, and informed consent documents.
• Ensure clinical studies are conducted in compliance with FDA regulations, IRB/EC requirements, and Good Clinical Practice (GCP).
• Oversee investigator and site selection, site initiation, and ongoing monitoring activities.
• Build and maintain strong relationships with investigators and site staff to support enrollment, data quality, and protocol adherence.
• Lead cross-functional study teams and provide regular updates to internal and external stakeholders.
• Develop and manage study budgets; proactively identify study risks and implement mitigation strategies.
• Oversee clinical data quality and support preparation of clinical study reports and regulatory submissions.

How You’ll Get There:

  • 8+ years of progressively responsible experience in clinical research within the medical device or pharmaceutical industry.
  • Demonstrated experience leading the execution of clinical studies or programs with responsibility for timelines, budgets, and cross functional coordination.
  • Prior experience providing day to day leadership, guidance, or oversight to study teams, vendors, or functional partners; people management responsibility may be direct or matrixed.
  • Strong working knowledge of FDA regulations, GCP, and global clinical research requirements, with the ability to apply policies and procedures to ensure compliant execution.
  • Proven ability to manage moderately complex initiatives, assess risks, and implement mitigation strategies to achieve study objectives.

Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.

Founded in 1998, Glaukos Corporation is an ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.

Our mission at Glaukos is to truly transform vision by pioneering novel, dropless therapies that can meaningfully advance the standard of care and improve the lives of patients suffering from chronic, sight-threatening eye diseases.

Innovation is at the core of everything we do, and we are resolute in our commitment to challenge conventional thinking with new treatment alternatives that are supported by real science, robust clinical evidence, and an unrelenting focus on patients.

Our constant pursuit of game-changing technologies that disrupt legacy treatment paradigms is encapsulated in the Glaukos mantra “We’ll Go First,” which articulates our willingness to take chances, our determination to forge new ground, and our commitment to continuous improvement in all that we do.

Our company completed an initial public offering in June of 2015, and our shares are traded on the New York Stock Exchange under the ticker symbol “GKOS”. Our global headquarters is in Aliso Viejo, California with additional locations in San Clemente, California, and Burlington, Massachusetts.

Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

All offers of employment are contingent upon the successful completion of a background check, including successfully passing a drug screen, based on the position and local regulations.

Glaukos Corporation

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