Clinical Trial Manager Job Description Template
The Clinical Trial Manager will be responsible for the overall management and coordination of clinical trials. They will work closely with the Principal Investigator to develop study protocols, manage patient recruitment, and ensure that all aspects of the trial are conducted according to Good Clinical Practices. The Clinical Trial Manager will also be responsible for data collection and analysis, as well as preparing reports for sponsors and regulatory agencies.
Clinical Trial Manager Job Responsibilities
- Oversee the clinical trial process from start to finish, including design, implementation, and analysis
- Serve as the primary point of contact for sponsors, investigators, and other study personnel
- Ensure that all clinical trials are conducted in accordance with Good Clinical Practices (GCP) guidelines
- Develop and maintain relationships with key opinion leaders in the field to ensure successful recruitment of patients for clinical trials
- Manage budgets and timelines for assigned clinical trials
Objectives
- Design and implement clinical trials in accordance with Good Clinical Practice and applicable regulations
- Develop clinical trial protocols and related documents
- Select, initiate, and maintain relationships with clinical research sites
- Coordinate study start-up activities with research sites, including IRB/IEC submission and approval process
- Manage day-to-day operations of the clinical trial, including site management, data collection, safety reporting, and closeout
- Ensure compliance with regulatory requirements throughout the conduct of the trial
- Monitor progress of the clinical trial against timelines and budget
- Prepare reports for sponsors/CROs and present results at internal and external meetings
- Maintain knowledge of current trends in clinical research
Clinical Trial Manager Job Skills & Qualifications Needed
- The skills and qualifications needed for the role of Clinical Trial Manager vary depending on the employer, but typically include a bachelor's degree in a scientific discipline, experience working in clinical research, and project management experience. Some employers may also require certification from the Association of Clinical Research Professionals (ACRP) or the Society for Clinical Research Associates (SOCRA).