ClinOps Collective

The Career
Operating
System
for ClinOps.

Maps, tools and a community for every stage of the climb: breaking in, becoming a CRA, and running studies like a senior.

Find Your Path
Free to start · Joins you to the Collective
Break In Become a CRA Run the Study 550+ in the Collective Built by a Practitioner
80%
of trials miss enrolment timelines
11%
of interested patients are enrolled
£8M
lost per month of timeline delay
11
tabs covering every dimension of start-up
The Path

Nobody shows you the path.
So we wrote it down.

The route through a clinical operations career is unwritten. Seniors know the rules; nobody hands them over. ClinOps Collective exists to write them down, with a system and a room for every stage.

Stage 01
Break in.

For CTAs, CRCs and research nurses working out where a ClinOps career can go, and which route in is theirs.

Career Navigator — free
The Roadmap — coming soon
The Playbook — coming soon
Find Your Path
Stage 02
Become a CRA.

For the ones ready to make the move into monitoring: the evidence, the ask, and the first 90 days.

CRA-Ready Profile — free
Founding Cohort — by application
CRA-Ready Toolkit — coming soon
Build Your Profile
Stage 03
Run the study.

For study managers and start-up specialists running delivery, with the systems seniors actually use.

Study Start-Up Toolkit™ — available now
Start-Up Accelerator — for teams
 
Get the Toolkit
What's included

Not a checklist. A complete operating system.

Most start-up tools give you a checklist. This gives you a system — where milestones auto-date, risks auto-score, and KPIs auto-RAG from a single anchor date.

Enter your FPFV date. Your entire start-up plan is ready in under 10 minutes.

Tab 01
Milestone Planner
~60 milestones auto-date from your FPFV anchor. Status dropdowns with auto RAG. Week -26 to post-FPFV.
Tab 02
Task Tracker
80+ tasks across study set-up, database, conduct, and close-out. Full lifecycle from concept to CSR.
Tab 03
Recruitment Tracker
Per-site forecast vs actual. Auto-calculates screen failure rate and screen-to-randomisation conversion.
Tab 04
Recruitment Contingency
Site-level escalation monitoring with a 15-strategy contingency menu — from DCT expansion to community navigator deployment.
Tab 05
Investigator Selection
Full site tracking from first contact through SSV to selection decision and SIV scheduling.
Tab 06
Comms & HR Plan
Stakeholder matrix covering internal, CRO, vendor, PAG, site, and patient-level contacts with meeting cadence.
Tab 07
Risk Register
15 pre-populated risks. Auto RAG scoring via probability × impact. Covers feasibility, regulatory, diversity, compliance.
Tab 08
KPI Dashboard
20 KPIs with auto RAG against benchmark targets. Ready to share with Sponsors and CROs as a governance report.
Who it's for

Built for the professionals who actually run studies.

Whether you're stepping up to your first study manager role or running a lean biotech with no full ops team — this was built for you.

Senior CRAs
Preparing for promotion. Show your next line manager you already think like a study manager.
CTMs & Study Managers
Managing your first study independently. Impress sponsors with governance infrastructure from day one.
Start-Up Specialists
A ready-to-use system that covers every dimension of start-up without building from scratch each time.
Small Biotech Sponsors
Seed, Series A, virtual biotech. Professional-grade planning infrastructure at a fraction of the cost of consulting.
The problem it solves

Most study teams are still building the plane mid-flight.

Without the toolkit
  • Milestones tracked across disconnected spreadsheets
  • No unified view of risk, recruitment, and governance
  • ICH E6(R3) and diversity requirements missed at start-up
  • KPIs reported reactively rather than governed proactively
  • Every study rebuilt from scratch
  • Screen failure problems identified too late to fix
With the toolkit
  • One file. Every dimension of start-up in a single system
  • Enter FPFV date — entire milestone plan auto-populates
  • ICH E6(R3) and diversity tasks built in from week -26
  • 20 KPIs with auto RAG — governance-ready from day one
  • Reusable across every study you ever manage
  • Escalation triggers defined before problems emerge
About ClinOps Collective

Built by a practitioner.
Not a consultant.

Built by a clinical operations professional with 20+ years of global study leadership across top-tier pharma. Every task, risk, and KPI in this toolkit comes from real programme delivery — not theory.

20+
Years global study leadership
11
Tabs in the toolkit
80+
Pre-built tasks
2025
ICH E6(R3) aligned edition
Free Resource

Not ready to buy yet? Start here — for free.

Download the free COC Study Start-Up Milestone Planner: 17 milestones from Week −26 to FPFV. Printable. Usable today. No email required.

Download Free Template No email required · Instant download · PDF
Free Tool

Not sure where your ClinOps career goes next?

Answer 5 questions and get your personalised ClinOps career pathway: your specialism, your next role, and the steps to get there.

Free Tool · Cohort Application

Ready to move from CTA to CRA?

Build your CRA-Ready Profile: six sections covering your experience, stakeholders, confidence, and commitment. You'll get an honest readiness read and a downloadable profile. Send it to us and it doubles as your application to join the founding cohort, the first room of the Collective.

What you answer
Your role and setting. The stakeholders you've worked with and the systems you know. Your evidence so far, four honest confidence ratings, and why a CRA, why now.
What you get
Your readiness band, showing where you genuinely are on the path, plus your CRA-Ready Profile to download. Send it in and we reply with an honest read on cohort fit.
Build Your Profile Free · ~7 minutes · Founding cohort places by application
The Suite

One collective. Every stage of your ClinOps career.

Every product comes with membership of the Collective: a community of clinical operations professionals navigating the same path. Buy once, and you have a place in the room.

01 — Self-Serve
The Toolkits
Professional-grade systems you download and use immediately. Built from real programme delivery, not theory.
  • Study Start-Up Toolkit™ — available now
  • CRA-Ready Toolkit — coming soon
  • The Playbook — coming soon
  • Lifetime updates · membership of the Collective
Get Access
02 — The Cohort
CTA → CRA Founding Cohort
The heart of the Collective. A guided four-module programme, taken with a room of CTAs, CRCs and research nurses all making the same move into monitoring.
  • The Map · The Gap · The Ask · The Leap
  • Community of peers on the same path
  • Free live intro session
  • Founding places — by application
Build Your Profile
03 — For Teams
Start-Up Accelerator
For teams and sponsors who need expert implementation support.
  • Toolkit and training
  • 90-min strategy workshop
  • Recruitment strategy review
  • Risk register review
Enquire
Questions

Frequently asked.

What format is the toolkit?
Microsoft Excel (.xlsx). Compatible with Excel 2016 and later, and with Google Sheets (some formatting may vary in Sheets).
Do I need any special software or plugins?
No. The toolkit uses standard Excel formulas, dropdown validation, and conditional formatting. Nothing to install.
Is this suitable for all therapeutic areas?
Yes. The framework is therapeutic area agnostic. The milestone planner, risk register, and KPI dashboard apply across oncology, cardiovascular, neurology, rare disease, and all other indications.
Is it aligned to current regulations?
Yes. The 2025 edition is aligned to ICH E6(R3) which came into force in 2025, and integrates FDA and EMA diversity guidance throughout.
Can I use it across multiple studies?
Absolutely. One purchase gives you a reusable template you can copy and adapt for every study you manage. It is designed to be your permanent planning infrastructure.
What if I have questions after purchase?
Email theclinopscollective@gmail.com. We aim to respond within 2 business days.
Stay Connected

Join the
ClinOps
Collective.

Free resources, frameworks and insights for clinical ops professionals — delivered to your inbox.

550+ clinical operations professionals navigating their path. Insights, tools, and first access to everything we build, with the free Study Start-Up Milestone Planner waiting when you join.

Practical tools and frameworks
ICH E6(R3) and regulatory updates
Career elevation content
New product launches and offers
Free on sign-up
COC Study Start-Up
Milestone Planner
17 milestones. Week −26 to FPFV. Printable and usable today.
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ClinOps Collective

Every stage has a system.
Find yours.

Free to start · Joins you to the Collective

Find Your Path