What is Clinical Operations?

Are you looking to embark on a new career or maybe you are exploring the idea of a career change? If you have a background in life sciences or even chemicals and are looking for a rewarding career then the clinical operations sector could be perfect for you. As part of our 4 part series “fancy a career in clinical operations”, we will be releasing articles about this sector and the following article explains what clinical operations is:

Clinical trials require operational management and thus require key individuals to coordinate the project or particular phase of the drug development process.  These positions range from administrative roles or Clinical Trial Administrators, supporting the day to day activities for the trial, field-based monitors or Clinical Research Associates who travel to different Clinical Research Units to ensure the trial is running correctly, Clinical Study/Project Managers who manage the teams or running of the trial (usually on a region or global level)  to Directorship roles within clinical operations where the person will have sole responsibility of a trial.

Operational roles tend to focus on the smooth running of the clinical trial in accordance with trial protocol, GCP and ICH guidelines and the people tasked with these roles are measured based on whether the trial is on schedule and patient recruitment numbers are at required levels.  Operational jobs require individuals to be able to converse and liaise with key opinion leaders in the drug development process and thus require incumbents to have strong communication and influencing skills.

Clinical operations is a highly important part of the drug development process and encompasses the whole clinical trial process from phases I-IV.  This part of the process requires expertise, accuracy and speed, as it is essential for a drug to get to market as soon as possible in order for the pharmaceutical company to receive a return on their initial investment.  People working in clinical operations are usually paid very good remuneration due to the importance of their role and the responsibility it carries.  The jobs they work in, tend to be contractual due to the nature of the work, but there are permanent positions available also as companies will transfer their workforce from one project to another.

Read our guide to clinical operations

Read the CRA job profile

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