Our Clinical Trial Manager job description includes the responsibilities, duties, skills, education, qualifications, and experience.
About the Clinical Trial Manager role
Clinical Trial Managers are responsible for the operational and administrative management of clinical trial activities. They coordinate with internal and external stakeholders to ensure successful execution and completion of clinical trials. Clinical Trial Managers must remain up to date on regulations, standards, and best practices in the clinical trial industry. They must have excellent organizational, communication, and problem-solving skills.
Role Purpose
The purpose of a Clinical Trial Manager is to manage the day-to-day operations of clinical trials to ensure that they are conducted in accordance with the protocol, standard operating procedures, and applicable regulations. This includes but is not limited to, coordinating and tracking study activities, monitoring study progress, managing resources, and ensuring data integrity. Additionally, a Clinical Trial Manager will provide guidance to study team members, respond to queries from sponsors, serve as a liaison between the study sites and sponsors, and provide feedback to sponsors and study sites.
Clinical Trial Manager Summary
The Clinical Trial Manager is responsible for managing all aspects of clinical trials from protocol development to close-out. This includes developing study timelines, budgets and clinical trial agreements, as well as monitoring clinical sites for protocol compliance, maintaining data integrity, and ensuring regulatory compliance. The Clinical Trial Manager will also serve as a liaison to the study sponsors, Clinical Research Organizations (CROs) and the study sites, and will be responsible for the timely delivery of study results. The successful candidate will have excellent communication, organizational, and problem-solving skills, and have experience in the pharmaceutical or medical device industry.
Clinical Trial Manager Duties
- Planning and executing clinical trials for research studies
- Ensuring compliance with ethical and safety standards
- Collaborating with sponsors, investigators and vendors
- Developing protocols, case report forms and other study documents
- Managing recruitment, enrollment and data collection processes
- Monitoring the progress of clinical trials
- Reporting and analyzing trial results
Clinical Trial Manager Skills
- Excellent written and verbal communication
- Ability to manage multiple tasks and maintain organization
- Ability to work independently
- Ability to analyze and interpret clinical data
Clinical Trial Manager Requirements
- Manage clinical trials from development to completion
- Ensure compliance with relevant regulations and guidelines
- Develop timelines and budgets for clinical trials
- Coordinate and collaborate with stakeholders such as clinical research associates, data managers, and clinical trial sites
- Monitor and report on clinical trial progress
- Ensure data accuracy and quality
- Identify and resolve issues
- Provide support and guidance to study staff
- Maintain strong relationships with vendors
- Negotiate contracts with external vendors
Personal Traits
- Leadership
- Organizational
- Time Management
- Communication
- Problem Solving