Our Clinical Study Manager job description includes the responsibilities, duties, skills, education, qualifications, and experience.
About the Clinical Study Manager role
A Clinical Study Manager is responsible for managing clinical trials and ensuring they are conducted according to Good Clinical Practice (GCP) guidelines and applicable regulations. They may also be involved in protocol design, site selection, data collection and management, monitoring, and reporting. Clinical Study Managers must possess strong organizational and communication skills, as well as a thorough understanding of GCP and FDA regulations.
Role Purpose
The purpose of a Clinical Study Manager is to plan, organize, and manage clinical studies from start to finish. This includes developing study protocols, overseeing regulatory compliance, managing patient recruitment and retention, coordinating data collection and analysis, and reporting results. Clinical Study Managers ensure that all clinical studies are conducted according to applicable regulations and guidelines, and that data is accurate, timely, and of high quality.
Clinical Study Manager Summary
The Clinical Study Manager is responsible for managing all aspects of clinical research studies, from study start-up through close-out. This includes developing and managing study budgets, timelines, and resources; liaising with study sites and clinical research personnel; monitoring data for accuracy and compliance with study protocols; and preparing and submitting reports to regulatory bodies. The Clinical Study Manager must also ensure that all study activities comply with applicable laws and regulations, and must ensure quality assurance of data and processes.
Clinical Study Manager Duties
- Organize and coordinate clinical studies in accordance with set protocol and standards
- Develop study plans, budgets and timelines for clinical studies
- Manage study records and reports, including data entry and storage
- Supervise and monitor clinical sites to ensure proper study administration
- Perform site visits to assess study progress and compliance
- Train and assist sites with study procedures and data entry
- Collaborate with clinical research teams to ensure successful execution of clinical studies
Clinical Study Manager Skills
- Excellent communication and organizational skills
- Attention to detail
- Ability to manage multiple projects
- Knowledge of clinical research processes
- Proficient computer skills
Clinical Study Manager Requirements
- Bachelor's degree in a health-related field
- Strong project management skills and experience
- Knowledge of clinical research regulations
- Excellent communication, organizational and problem-solving skills
Personal Traits
- Excellent organizational skills
- Strong communication skills
- Ability to work independently
- High level of attention to detail