Clinical Trial Manager

Overview

• Lead clinical trial operations for Phase 1 studies focusing on healthy volunteers.
• Ensure compliance with regulatory requirements and maintain inspection readiness.
• Collaborate globally with cross-functional teams to achieve clinical objectives.
• Develop strategies for clinical operations programs and trial execution.
• Drive site selection and subject recruitment to meet enrollment targets.
• Oversee budgets, timelines, and vendor management for clinical trials.
• Contribute to the creation of regulatory documents and training materials.
• Implement efficient processes to enhance clinical operations performance.
• Support global trials with a focus on reliability, efficiency, and quality.

Key Responsibilities & Duties

• Develop and execute clinical trial strategies and methodologies.
• Ensure trials comply with FDA, EMEA, ICH, and GCP guidelines.
• Manage budgets, contracts, and vendor relationships effectively.
• Collaborate on training materials and clinical development plans.
• Drive patient recruitment and site selection to meet targets.
• Participate in SOP development and departmental training activities.
• Provide strategic input for regulatory submissions and clinical documents.
• Monitor trial progress and proactively address risks.
• Lead cross-functional collaborations to achieve trial objectives.

Job Requirements

• Master's degree in Science (M.S) with 10+ years of clinical operations experience.
• Expertise in FDA, EMEA, ICH, and GCP regulatory guidelines.
• Proven ability to lead global clinical trials and manage budgets.
• Experience in patient recruitment, safety, and investigational product management.
• Strong skills in developing clinical protocols and SOPs.
• Track record of successful clinical trial planning and execution.
• Ability to drive process transformation and organizational change.
• Knowledge of global trial operations and compliance standards.
• Excellent communication and collaboration skills across teams.