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Clinical Operations

Clinical operations, held to the metrics you agreed.

Teams shaped to each sponsor programme, scaling from targeted functional support to full operational ownership.

The problem

Enrolment does not fail suddenly. It fails quietly for six weeks.

A site that has not screened a patient in a month is usually visible in the data long before it appears in a status report. What is missing is not the number, it is someone whose job is to notice it on the Tuesday and act on the Wednesday.

The second failure is vendor drift. A central lab changes a process, an IRT vendor updates a specification, and nobody connects it to the data management plan until reconciliation.

We staff for the noticing. Enrolment, timeline and quality metrics are agreed at the start, and someone owns them daily rather than monthly.

Talk to a specialist

Tell us the problem. A specialist replies, not a form robot.

What we do

What the team owns.

01

Feasibility and site selection

Realistic assessment of who can actually enrol, not who says they can.

02

Start-up

Contracts, essential documents and activation tracked to a critical path.

03

Enrolment oversight

Weekly visibility, and escalation when a site stalls rather than at the monthly review.

04

Vendor oversight

Central labs, IRT, imaging and couriers held to their own specifications.

05

Inspection readiness

Maintained throughout rather than assembled in the fortnight before.

06

Issue escalation

A defined path, so problems reach someone with authority early.

For consultants

Roles we place in clinical operations.

This is one of our highest-volume disciplines. If your background is here, we should be talking whether or not something is posted.

  • Clinical Research Associates, all levels
  • Clinical Trial Assistants
  • Study and Site Managers
  • Clinical Operations Leads
  • Start-up and Regulatory Specialists
  • Vendor and Outsourcing Managers

Send your resume

Proof

Daily, not monthly

How often enrolment and quality metrics are actually looked at.

Client testimonials for this discipline are being collected and will appear here once approved in writing by the clients concerned.

Questions

Questions we get asked.

Can you provide a single CRA rather than a team?

Yes. A large share of what we do is single-role functional support, and it is often how a longer relationship starts.

Do you work sponsor-side or CRO-side?

Both. The work differs more than people expect, and we screen for which environment someone has actually operated in.

Can you rescue a study that has drifted?

Yes, starting with an honest assessment of where it actually is, which is sometimes not where the last report said.

Onsite, remote or hybrid?

All three. Site-facing roles usually need presence; oversight and start-up work often does not.

How quickly can you cover a resignation?

Profiles within 48 hours for most operations roles. Notice periods, not sourcing, are normally the constraint.

Related

Where to go next.

Trial management

Modular delivery across the study lifecycle.

Read more ›

Clinical monitoring

Risk-based monitoring and central oversight.

Read more ›

For consultants

Send your resume and we go to market for you.

Read more ›

Talk to someone who has done this.

Hiring for it, or looking for the work. Either conversation is welcome.

Contact usSend your resume