Manager Study Start-up

Glaukos Corporation • San Clemente, CA

2d

About The Position

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.

Requirements

• 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.

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: No Education Listed