Summary
The Clinical Trial Manager is responsible for the overall management of clinical trials, from study initiation to completion. The Clinical Trial Manager will work closely with study investigators, sponsors, and regulatory agencies to ensure that trials are conducted in a safe and ethical manner and that data is collected and analyzed in accordance with Good Clinical Practice (GCP) guidelines.
Responsibilities
- Plan and manage clinical trials. This includes developing trial protocols, recruiting participants, and overseeing the conduct of trials.
- Ensure that trials are conducted ethically and in accordance with regulations. This includes reviewing study protocols and ensuring that they meet ethical standards, and monitoring the conduct of trials to ensure that they are conducted in accordance with regulations.
- Oversee the conduct of trials. This includes ensuring that trials are conducted according to the study protocol, resolving any issues that arise during the course of a trial, and ensuring that trials meet their objectives.
- Report on the progress of trials. This includes providing regular reports to stakeholders, such as the study sponsor, regulatory agencies, and ethics committees.
- Communicate with stakeholders. This includes communicating with the study sponsor, regulatory agencies, ethics committees, and study participants.
- Advocate for the rights of study participants. This includes ensuring that study participants are treated fairly and that their rights are protected.
Qualifications
- Master’s degree in a related field, such as clinical research, biostatistics, or epidemiology
- Experience in clinical trial management
- Strong organizational and time management skills
- Excellent communication and interpersonal skills
- Ability to work independently and as part of a team
- Proficient in Microsoft Office Suite
- Experience with a variety of clinical research software programs.
Skills
- Strong understanding of clinical trial principles and practices
- Excellent organizational and time management skills
- Excellent written and verbal communication skills
- Ability to work independently and as part of a team
- Experience with regulatory compliance