Clinical Trial Manager

Clinical Trial Manager Overview

• The Clinical Trial Manager (CTM) oversees Phase I and II clinical trials, ensuring high-quality execution and compliance with regulatory standards.
• Leads cross-functional teams and collaborates with vendors to deliver trials on time and within budget.
• Applies expertise in clinical operations and project management to proactively address risks and maintain study timelines.
• Ensures adherence to protocols, ICH GCP guidelines, and applicable regulations throughout the trial lifecycle.
• Drives site feasibility, selection, and activation strategies in collaboration with stakeholders.
• Provides leadership in trial documentation, data review, and quality assurance processes.
• Fosters collaboration across internal teams, vendors, and site staff to achieve trial objectives.

Clinical Trial Manager Key Responsibilities & Duties

• Lead operational planning and execution of global clinical trials, ensuring compliance with quality standards.
• Oversee trial documentation and systems, maintaining accuracy and inspection readiness.
• Manage CROs and service providers, ensuring timely and high-quality deliverables.
• Identify, assess, and mitigate operational risks using risk-quality management approaches.
• Review clinical data, quality metrics, and protocol deviations, escalating challenges as needed.
• Provide input into study protocols, investigator brochures, and study-specific plans.
• Monitor trial performance, data quality, and budgets using metrics and dashboards.
• Collaborate across functional teams to drive decision-making and continuous improvement.

Clinical Trial Manager Job Requirements

• Bachelor’s degree in life sciences, health sciences, nursing, pharmacy, or related field; advanced degree preferred.
• Minimum of 8 years of clinical trial management experience; 10 years preferred.
• Proficiency in clinical trial systems such as CTMS, eTMF, and EDC platforms.
• Solid understanding of ICH/GCP regulations and clinical drug development lifecycle.
• Experience managing global, multicenter trials in a matrixed organization.
• Strong communication, project management, and vendor oversight skills.
• Ability to lead without authority and mentor cross-functional teams.
• Willingness to travel domestically and internationally up to 10%.