Clinical Trial Manager - Remote

Overview

The Clinical Trial Manager is responsible for the overall management, planning, implementation, and execution of clinical trial(s) in a fast-paced environment with moderate oversight from the Senior Clinical Trial Managers and/or Associate Director, Clinical Operations.

In Short

• Leads and assists the trial team to execute and deliver the clinical trial in accordance with the clinical development plan/strategy, budget and timeline.
• Authors clinical trial documents and trial-related plans.
• Contributes to the clinical review of CRFs and the data review plan.
• Leads in the identification and selection of investigator sites.
• Responsible for planning and conducting Investigator's Meetings.
• Coordinates delivery of clinical trial supplies.
• Collaborates with the cross-functional team on selection and management of clinical trial vendors.
• Monitors and manages budget for clinical trial(s).
• Reviews clinical monitoring reports and correspondence.
• Provides periodic status reports regarding trial timelines and budget issues.

Requirements

• B.S/B.A. degree is required; Science/health care related field preferred.
• 5+ years' experience in a pharmaceutical/biotech company or CRO.
• 2+ years’ experience managing clinical trials.
• Ophthalmology, Nephrology, Hematology experience preferred.
• Ability to manage multiple competing tasks and deadlines.
• Excellent written and verbal communication skills.
• Strong knowledge of project management software, including Microsoft Suite.
• Knowledge of regulatory requirements governing clinical research.
• Ensure trial adherence to ICH/GCP/local regulations.
• Ability to lead a cross-functional team.

Benefits

• Comprehensive benefits package including 401(k) plan with company match.
• Inclusive family building benefits.
• Flexible time off, summer and winter shutdowns.
• Paid family leave, disability, and life insurance.