Clinical Trial Manager – Contract

• Support the Company's clinical trial activities and report to the Director of Clinical Operations
• Manage day-to-day operations of one or more Phase 1-3 clinical trials, including start-up, conduct, and close-out
• Serve as primary contact for protocol execution and oversee CROs, service providers, and consultants
• Lead cross-functional study execution teams and track study milestones, metrics, and timelines
• Ensure trials comply with ICH GCP, regulations, protocols, and company SOPs
• Prepare and review clinical trial documentation, including protocols, informed consent forms, investigator brochures, monitoring plans, project plans, CRFs, SAPs, and clinical study reports
• Establish and maintain the Trial Master File and support audit readiness and resolution of audit findings
• Participate in service-provider selection and support issue resolution and process improvement
• Assess operational feasibility, recommend study execution plans and site selection, and train CRO staff, monitors, sites, and service providers
• Facilitate clinical trial agreements with the legal group
• Manage clinical trial budgets, financial reporting, projections, site contracts, and invoices
• Perform ongoing data review and site visits, including qualification, initiation, monitoring, and close-out
• Oversee outsourced monitoring, protocol deviation tracking, clinical supplies forecasting, and site issue resolution
• May manage junior Clinical Operations staff and support Clinical SOP development
• Travel to sites, conferences, and industry meetings as needed

Requirements

• B.A./B.S. degree in Science
• 6+ years of clinical research experience within the Biotech or similar industry
• At least 2 years directly supporting a retina clinical trial
• Knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trial management
• Understanding of regulatory framework applicable to interactions with HCPs, payers, advocacy, and other business partners
• Proven clinical operational skills to direct protocol execution and meet timeline, budget, and quality metrics
• Experience reviewing trial plans, including site monitoring, risk mitigation, trial budgets, site selection, and clinical supplies management
• Clinical research knowledge and cross-functional understanding of clinical trial methodology
• Proficient Microsoft Office Suite skills, including Word, Excel, PowerPoint, and Outlook
• Working knowledge of MS Project for clinical study timelines
• Ability to travel as needed; stated travel expectation is 5%
• Global APAC experience desired

Core Competencies

Demonstrates expertise in managing clinical trial operations, ensuring compliance with GCP and ICH guidelines, and effectively overseeing cross-functional teams. Proficient in clinical trial documentation, budget management, and operational feasibility assessments.

Highest-signal resume keywords

• Clinical Trial Management
• GCP Compliance
• Protocol Execution
• Budget Management
• Cross-Functional Team Leadership

ATS Optimization Keywords

Hard Skills

• Clinical Research Experience
• Trial Documentation Preparation
• Site Monitoring
• Risk Mitigation
• Clinical Supplies Management
• Data Review
• Trial Master File Management
• Operational Feasibility Assessment
• Regulatory Requirements Knowledge
• Retina Clinical Trial Support

Soft Skills

• Problem Solving
• Communication
• Team Management

Industry Keywords

• Biotech
• ICH Guidelines
• Clinical Operations
• Audit Readiness
• Service Provider Selection
• Financial Reporting
• Site Contracts
• Global APAC Experience

Tools & Technologies

• Microsoft Office Suite
• MS Project