What is Clinical Operations?

If you want to find out what Clinical Operations are, you’ve come to the right place! Think of a burger. There’s the bun, the patty, the veggies, and the sauces. It is all too easy for the burger to fall apart if not handled correctly. That’s where the burger skewer, Clinical Operations, comes in. One stick that holds everything together. 

Think of Clinical Operations as this skewer. They attend every meeting, stay up-to-date on each front, and communicate moving parts to the rest of the team. Most importantly, they ensure patients are cared for. 

Let’s delve into fundamental aspects to discover its key components. 

 

What is Clinical Operations?

Clinical Operations is such a broad department. It is great for an individual who enjoys juggling different moving parts, keeping the ‘burger’ together. This part of clinical trials embodies this mentality: ‘a jack of all trades is a master of none, but oftentimes better than a master of one’. You get to move across departments and explore everything that the trial has to offer. 

 

So who are the stakeholders in a clinical trial?

There are many teams that have to work together to ensure the success of a clinical trial:

• Data Management
• Legal
• Marketing
• Pharmacovigilance
• Regulatory 
• Statistics 

 

Internal stakeholders are only some of the groups that they work with. They also work with external groups such as CROs and other vendors. 

Clinical Operations work hard to organise each part of the trial. Navigating the healthcare landscape is a complex endeavour, and they have to coordinate all of it. 

 

Why is Clinical Operations Important?

Clinical Operations are an important part of every clinical trial. Encompassing a broad range of activities, clinical operations touch on each part of a clinical trial. They plan the different parts of the trial and stay up-to-date with all of the stakeholders. They mingle with every stakeholder of the trial. Many departments would never interact without Clinical Operations. 

They often operate behind the scenes, and drive operational efficiency while optimising resources. 

 

Roles within Clinical Operations

There is a wide spectrum of Clinical Operation roles, ranging from:

•  Strategic Planning
•  Resource Allocation
•  Operational Management
•  Process Optimisation and more

Let’s take a look at the main Clinical Operation job roles.

 

Vice President

The Vice President of Clinical Operations heads the operations. 

They need to have a strong knowledge of each part of the trial. This is because a VP has to collaborate with cross-functional teams. 

They also oversee the planning, implementation and management of clinical trials. From Phase I to Phase III. Ensuring compliance with strict regulatory requirements and industry standards. 

VPs engage with and build strong relationships with all of the stakeholders involved in the process. 

They have to be proactive and identify potential risks. Strong leadership skills and a passion for life-altering treatments are a must for this role. Soft skills like interpersonal skills are vital for them to manage and lead their teams. VP’s provide guidance, mentoring and support. 

 

Director

If a firm doesn’t have a VP of Clinical Operations, there will likely be a director or multiple directors to spearhead different parts of the project. 

 

Clinical Project Manager

These roles closely manage budgets, timelines, resources and vendors. They communicate with internal and external stakeholders to create and oversee timelines. Provide regular updates on project progress, and are self-starters. These project managers liaise with Senior Management, communicating results.

 

Clinical Trial Manager

No day is the same for trial managers. They might manage one or multiple clinical trials. Some trial managers travel to support the execution of clinical studies. Clinical trial managers are hands-on to support the goal of the trial.

 

Clinical Research Associate

These roles include a diverse group of applicants, ranging from biotech engineers, research assistants to nurses and more. This can either be an entry level job, taking an individual with the right background in healthcare to act as a research associate, or a senior job. The senior role might be a candidate with experience in clinical research or who have gone through CRA training. 

CRA’s are critical thinking problem solvers. They have a basic knowledge of clinical research regulatory requirements. They may even work on site monitoring, managing the progress of studies and evaluate the integrity of study site practices.

 

Clinical Trial Assistant

This is an entry level administrative role. This role assists CRA’s with assigned projects and reports daily to their CRA. Their goal may be to join a role that can grow into a project management role. 

 

Conclusions

Clinical Operations plays a crucial role in the success of clinical trials. Just like a skewer holds a burger together, They coordinate various stakeholders and ensure the smooth functioning of all trial components. From Vice Presidents to Trial assistants, each role contributes to the overall effectiveness of the department. This is a dynamic department that spans a broad range of roles and functions.