Clinical Trial Manager – Contract

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

📋 Description

• Assist with the Company's clinical trial operations and report directly to the Director of Clinical Operations.

• Oversee daily activities of one or more Phase 1–3 clinical trials, including initiation, execution, and completion.

• Act as the main point of contact for protocol implementation and manage CROs, service providers, and consultants.

• Lead interdisciplinary study execution teams and monitor study milestones, metrics, and timelines.

• Ensure compliance with ICH GCP, relevant regulations, protocols, and company SOPs throughout the trials.

• Prepare and review essential clinical trial documentation, such as protocols, informed consent forms, investigator brochures, monitoring plans, project plans, CRFs, SAPs, and clinical study reports.

• Create and maintain the Trial Master File while supporting audit preparedness and addressing audit findings.

• Engage in service-provider selection and assist with issue resolution and process enhancements.

• Evaluate operational feasibility, propose study execution strategies and site selections, and train CRO staff, monitors, sites, and service providers.

• Facilitate the negotiation of clinical trial agreements with the legal department.

• Manage clinical trial budgets, financial reports, projections, site contracts, and invoices.

• Conduct ongoing data assessments and site visits, including qualification, initiation, monitoring, and closure activities.

• Supervise outsourced monitoring, track protocol deviations, forecast clinical supplies, and resolve site-related issues.

• May oversee junior Clinical Operations personnel and assist in developing Clinical SOPs.

• Travel to sites, conferences, and industry events as necessary.

⛳️ Requirements

• Bachelor’s degree in Science (B.A./B.S.).

• Over 6 years of experience in clinical research within the Biotech or a comparable industry.

• A minimum of 2 years of direct experience supporting a retina clinical trial.

• Familiarity with GCP, ICH guidelines, and regulatory standards pertinent to clinical trial oversight.

• Understanding of the regulatory framework governing interactions with healthcare professionals, payers, advocates, and other business partners.

• Demonstrated clinical operational expertise to guide protocol implementation and achieve timeline, budget, and quality benchmarks.

• Experience in reviewing trial plans, encompassing site monitoring, risk management, trial budgets, site selection, and clinical supplies oversight.

• Comprehensive knowledge of clinical research and a cross-functional grasp of clinical trial methodologies.

• Proficient in Microsoft Office Suite, including Word, Excel, PowerPoint, and Outlook.

• Working knowledge of MS Project for managing clinical study timelines.

• Willingness to travel as necessary; anticipated travel is approximately 5%.

• Global APAC experience is preferred.

🏝️ Benefits

• Equal employment opportunities regardless of protected characteristics.

• Travel as required to sites, conferences, and industry gatherings.

• Opportunities for professional growth through internal training and attendance at external conferences.