Clinical Trial Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the daily operational execution of one or more clinical trials from initiation to completion.

• Propel study timelines, ensure quality, and resolve issues effectively.

• Create and uphold study timelines, clinical plans, risk management strategies, and operational trackers.

• Raise concerns proactively to prevent impacts on delivery.

• Manage relationships with CROs, central laboratories, imaging vendors, and assess site performance.

• Hold vendors accountable for adhering to scope, quality standards, and timelines.

• Monitor enrollment, completion of monitoring visits, and assess data quality metrics.

• Initiate corrective actions as necessary.

• Ensure compliance with GCP, the study protocol, and relevant regulations.

• Maintain readiness and completeness of the trial master file for inspections.

• Monitor study expenditures against the budget.

• Identify budget discrepancies and assist in invoice and payment reviews.

• Collaborate with cross-functional stakeholders to ensure alignment of study execution with overall program strategy.

• Provide timely updates regarding study status, risks, and timelines to program leadership.

⛳️ Requirements

• Generally, 3-5 years of experience in Clinical Operations, including direct involvement in study startup, vendor management, and compliance oversight.

• A Bachelor’s degree is required; an advanced degree is advantageous but not mandatory.

• Strong knowledge of clinical trial execution across various study phases.

• Experience in ophthalmology or retina is highly preferred.

• Demonstrated ability to manage CROs, vendors, and study sites effectively.

• Comprehensive understanding of GCP and clinical trial regulations.

• Experience with regulatory agency inspections is preferred.

• Capability to lead cross-functional study teams and engage directly with external vendors and study sites.

• Excellent organizational and communication abilities.

• Skill in managing competing priorities across multiple studies.

• High standards of integrity and reliability.

• Comfort in working with a significant degree of independence.

• Applicants must possess authorization to work in the United States.

🏝️ Benefits

• Equity.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k).

• Accrued paid time off policy.

• Competitive salary.

• Strong equity incentives.

• Commitment to diversity, equity, and inclusion.