The Clinical Operations function of a company is key to the delivery of clinical trials. Without this team no Clinical Research activity could be delivered. Clinical Operations teams are responsible for designing, planning and physically running Phase I – IV clinical trials.
Depending on the size and type of clinical trial being conducted Clinical Operations teams can be either small regional teams or large International groups of people.
Clinical Operations teams are often made up of people like Clinical Operations Directors, Clinical Program Leaders, Clinical Trial Managers / Clinical Project Managers, Clinical Research Associates and Clinical Trials Administrators.
All of whom play their part in setting up and gathering the vital data relating to how volunteers and patients respond to the investigational new drug.
Clinical Operations have a lot of interaction with people in a range of other departments including Clinical Science, Clinical Quality Assurance, Data Management, Biostatistics and Regulatory Affairs to ensure that the data and information needed by these other departments is delivered so they can decide if a trial has been successful.
Many larger pharmaceutical companies have also looked at setting up strategic partnerships with Clinical Research Organisations to outsource some or all of their Clinical Operations activities.
This has presented some fantastic opportunities for Clinical Operations professionals to work in multiple therapeutic areas for a range of different companies too.
The below section gives some great information about working in a Clinical Operations role:
- What is Clinical Operations and why should I think about a career in this sector?
- How do I get into clinical operations?
- An interview with a CRA
- An interview with a clinical research nurse
- A day in the life of a CRA
- Where can this career take me?
- The demand for CRA’s continues to grow