The Clinical Operations group (otherwise known as “Clin Ops” works at the heart of clinical trials.
However, other groups, even those working within biotech or pharma companies, frequently don’t understand its function. It’s also hard to explain its function concisely because there’s more than one.
However, it’s crucial for everyone to understand Clin Ops’ importance. After all, “important” groups are given more resources from management and assistance from adjacent groups.
In this article, we summarize Clinical Operations (as they function within Sponsor companies). If you’re in Clin Ops and someone asks what you do, simply send them here!
Clinical Operations is the Glue Between Stakeholders
Typically, teams carrying out clinical trials are cross-functional. This means representatives from different departments form the team. You can think of Clinical Operations as the department within the spoke of a wheel. Other departments radiate from this spoke:
- Clinical Science
- Data Management
- Statistics
- Safety (Pharmacovigilance)
- Regulatory
- Legal
- Marketing
Clin Ops communicates with each groups regularly. This ensures they’re up-to-date on the trial information relevant to them. Some groups would never interface if it weren’t for Clin Ops facilitation. And in a project as complex as a clinical trial, it’s important that all are marching to the same beat in terms of strategies, risks, and current information.
Not only does Clinical Operations need to work with internal groups, but also with external:
- Contract Research Organizations (CROs)
- Central Lab Vendor
- Central Imaging Vendor
- ePRO Vendor
- IXRS Vendor
- Specialty Lab Vendors
- Other Study Vendors
Again, some of these groups would never interact if not for Clin Ops, yet need to.
- Example: Perhaps your Specialty Lab needs a monthly data output from the EDC system. However, you’ve outsourced Data Management and EDC maintenance to your CRO. Clin Ops needs to arrange this.
- Example: A site asks your CRO why their subject’s scan wasn’t read even though it was received weeks ago. Clin Ops needs to liaise with Central Imaging Vendor on behalf of the CRO.
And people ask why Clin Ops teams are always in meetings!
Clinical Operations Executes the Trial
The Clinical Trial Protocol is the recipe for how the trial is carried out.
The Protocol describes activities such as stats analysis, safety reporting, and medical monitoring. However, the bulk describes Subject Study Procedures.
Who’s responsible for preparing for, executing, and managing these procedures? Who’s responsible for sourcing and activating the sites that will provide the subjects for these procedures? You got it – Clin Ops.
Here are some common Clin Ops activities:
- Clinical Trial Tracking:
- Site Activation
- Screening and Recruitment
- Protocol Deviations
- To name just few!
- Vendor Evaluation, Selection, Management
- CRO Evaluation, Selection, Management
- Internal/External Meeting Faciliation Management (see section above).
- Regulatory/Audit Inspection Readiness
- Study Timeline Management
- Site Recruitment, Activation, and Motivation
- Various Site Trainings
- …the list goes on!
Now within each activity lies sub-activities! Let’s take site activation for example:
- Evaluate sites (in conjunction with other groups)
- Track site activation milestones
- Send feasibility questionnaire (FQ)
- Review FQ
- Perform Pre-study Visit (PSV)
- Review PSV report; select site
- Send site selection letter
- Send regulatory (start-up) package
- Review site-specific ICF
- Review site budget
- Answer site questions
- Perform Site Initiation Visit (SIV)
- Review IP Review Checklist
- Activate site in IXRS
- Send site activation letter
- 12/14 bullets above are done for each site! And a clinical trial can have hundreds of sites.
Additionally, all this work has to be done with rigor (no shortcuts) per country-specific Regulations and Good Clinical Practice.
You can see the breadth of work that Clin Ops groups cover. And within this breadth, they must track tiny details. The flexibility, collaboration, and organization required of this job is large. So be kind to your Clin Ops colleagues! Fulfill their requests in a timely/accurate manner to help ease their burden.
Roles within Clinical Operations
Now let’s talk about different roles within Clinical Operations:
- VP, Clinical Operations: This is the department’s head.
- Director, Clinical Operations: If there’s no VP at the company, there will almost always be a Director. If there is a VP, then there may be one or more directors, usually split by therapeutic area.
- Clinical Program Manager: This person oversees a clinical “program”. A program is usually a collection of trials testing the same compound (drug). However, it can also be a collection of trials within a therapeutic area.
- This person may also manage timelines, budget, risks, and resourcing for each clinical trial.
- They may also represent Clinical Operations during high-level cross-functional meetings and be the Point Person for Company Executives.
- Clinical Trial Manager (Clinical Operations Managers): This person usually oversees one clinical trial. However, it’s not unusual for them to oversee multiple if the trials are small.
- In general, they’re responsible for all the tactical activities of running a trial.
- We earlier wrote that Clin Ops lies at the heart of clinical trials. This role is the heart’s pacemaker!
- In-House Clinical Research Associate (Clinical Study Management Associate)
- This person assists the Clinical Trial Manager tactical activities.
- There’s much overlap between this role and Clinical Trial Manager
- Field Clinical Research Associate (Monitor): This person is the main liaison between the Sponsor company and a clinical site.
- They perform onsite monitoring visits.
- While onsite, they review medical records (source docs) against the clinical trial database.
- They help the site execute the protocol.
- Many companies outsource this role to a CRO.
- Clinical Trial Assistant (Clinical Research Assistant)
- This person performs the trial’s administrative tasks, such as tracking, follow-up, and e-TMF filing and review.
