United Kingdom · Operations · Mid-Level (2-5 years)

Clinical Operations Specialist

As a Clinical Operations Specialist, you ensure every clinical trial document is exactly where it should be, every time.

Here is the whole job, in plain words. What it is, a real day, what you decide, how you're judged, how people get here and where they go next. Then the part no course gives you: twelve AI tutors who learn your work.

Free to start: a plan built for this role, and a Future Fluency module to try first. No card.

Keep this job description

Where should we send it?

One email: what AI is changing in this job, and where to start free. With a link back here. Nothing else follows unless you confirm your address.

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  • Experience bandMid-Level (2-5 years)
  • Direct reportsNo direct reports
  • Reports toSenior Clinical Operations Specialist or Lead Clinical Operations Specialist
  • UK framework levelUsually a coordinator, or early in a professional job

Also advertised as Clinical Trial Specialist · Clinical Study Coordinator (Industry) · Clinical Research Associate (Office-based)

Built on 43,079 real UK job descriptions we analysed · grounded in qualifications employers recognise

1From this job to a course

The qualifications matched to this job

TQUK Level 3 Diploma in Healthcare Support Work (RQF) Training Qualifications UK Ltd · Level 3 · covers 1 of 5 standards
Pearson BTEC Level 4 Diploma in Healthcare Science Pearson Education Ltd · Level 4 · covers 1 of 5 standards
FDQ Level 3 Certificate for Proficiency in Food Manufacturing Excellence FDQ Limited · Level 3 · covers 2 of 5 standards
FDQ Level 3 Diploma for Proficiency in Food Manufacturing Excellence FDQ Limited · Level 3 · covers 1 of 5 standards
GQA PAA\VQ-SET Level 3 Diploma for a Bulk Storage Operator (Technician) GQA Qualifications Limited · Level 3 · covers 1 of 5 standards

Matched from the standards this job is measured against: a suggestion, not an official ruling.

The units you would start with

Conduct routine maintenance on clinical equipment TQUK Level 3 Diploma in Healthcare Support Work (RQF)
Clinical Engineering Workshop Skills Pearson BTEC Level 4 Diploma in Healthcare Science
Principles of Safe Manufacture of Quality Medicines in the Pharmaceutical Environment Open Awards Level 3 Technical Occupational Entry in the Principles and Practice for Pharmacy Technicians (Diploma)
Manage compliance to support achieving excellence in food operations FDQ Level 3 Certificate for Proficiency in Food Manufacturing Excellence
Comply with External and Internal Obligations within a Bulk Storage Operations Environment GQA PAA\VQ-SET Level 3 Diploma for a Bulk Storage Operator (Technician)

The future skills this job leans on

AI Fluency working with AI as a thinking partner
Data Fluency turning numbers into a decision
Automation Fluency building AI into how work runs
Your Plan Illustration

Built for Clinical Operations Specialist

5 units that map to this job, from the qualifications that cover it.

  1. Conduct routine maintenance on clinical equipment Training Qualifications UK Ltd · covers 1 of 5 standards Level 3
  2. Clinical Engineering Workshop Skills Pearson Education Ltd · covers 1 of 5 standards Level 4
  3. Principles of Safe Manufacture of Quality Medicines in the Pharmaceutical Environment Open Awards · covers 3 of 5 standards Level 3
  4. Manage compliance to support achieving excellence in food operations FDQ Limited · covers 2 of 5 standards Level 3
  5. Comply with External and Internal Obligations within a Bulk Storage Operations Environment GQA Qualifications Limited · covers 1 of 5 standards Level 3
These are the real units behind this job, in the order they rank for it. Nothing here is marked done, because this plan has not been started by anyone yet. Yours would fill in as you go.

2AI and this work

Will AI change your work as a Clinical Operations Specialist?

Nobody can say exactly how. Here is what this job is being asked for next, and where to start.

How the AI economy is changing work like this

A broad read on this kind of work, not an analysis of this job on its own. Roles that share a pattern get the same answer here.

Fading: AI does more of this

AI is beginning to take over routine document review and quality control tasks, freeing up your time for more complex issues.

→
Rising: worth more because of AI

Your ability to interpret nuanced regulatory requirements and foresee potential issues becomes even more valuable.

The new skills this role is being asked for

  • AI-Assisted Document Review & QC
  • Digital Literacy & Automation Mindset
Why each one is rising

The future skills this job leans on

We'll only ever tell you what we can actually back up. No hype, no scare tactics.

What happens when you start

Next, a free account. We build your Clinical Operations Specialist plan as you set up, starting with a Future Fluency module on using AI in your job. No card.

Your first Future Fluency module is free. After that, your AI tutor is £70 a month.

3What this role really is

We see you

You worry that AI might replace some of the repetitive tasks you handle daily, but you know your attention to detail and problem-solving skills are irreplaceable. Balancing technology with human oversight is your silent challenge.

A Clinical Operations Specialist keeps clinical trials running smoothly, making sure paperwork, systems and sites are ready for patient enrolment.

4A day in the life

Not a job advert. A real day, built from what this role actually holds.

08:45
You start your day by logging into the Clinical Trial Management System to update site contact details and check for any overnight changes.
11:30
A site coordinator rings with a query about a missing document, and you swiftly guide them through the resolution process, ensuring everything is accurately filed.
14:00
You perform a quality control check on the Trial Master File, meticulously identifying any missing or incorrect documents.
16:15
In the afternoon, you propose a new naming convention for documents to your manager, aiming to streamline the filing process.

5What you'd actually use

The tools this job runs on, and how well you'd need to know each one.

Veeva Vault eTMF or PhlexTMF Intermediate

Uploading, filing, and performing quality control checks on essential documents; resolving simple queries related to TMF content and structure.

Medidata Rave CTMS or Oracle Clinical One Intermediate

Entering and updating data for site visits, monitoring reports, and protocol deviations; running pre-built operational reports to track progress.

Medidata Rave EDC or Oracle InForm Basic

Running basic data validation reports; managing user access for site staff; tracking query aging and helping sites resolve simple data queries.

Updating task statuses, populating trackers with data, and following existing project plans for study start-up or document collection.

Viewing and exporting data from established dashboards (e.g., enrollment, site activation metrics) to provide updates to the team.

Suvoda, 4G Clinical, or Medidata RTSM (IRT/IXRS) Basic

Responding to site user queries regarding drug supply or randomisation; running basic drug supply reports; managing user accounts for sites.

6What you get to decide, and how that grows

Power in a job isn't your title. It's what you're allowed to decide. Here's how it grows as you move up.

The choiceComing in Where you are nowThe step above
TMF Document Filing & QC Files documents and performs basic QC under direct supervision; all findings reviewed. Independently files and performs comprehensive QC for assigned studies; escalates complex findings. Suggests minor process improvements. Oversees TMF health for multiple studies; designs and refines QC processes; trains junior staff on TMF best practices.
Site Query Resolution Escalates all site queries to supervisor; assists in drafting responses. Resolves routine site queries independently (e.g., system access, document requests); escalates complex issues. Acts as a primary point of contact for complex site queries; develops FAQs and training materials for common issues.
Operational Process Improvement Identifies minor inefficiencies and reports them. Proposes and implements minor process improvements within own scope of work (e.g., a new tracker, a clearer template). Leads small-scale process improvement projects (e.g., reducing site activation timelines); makes recommendations for broader changes.
Vendor Interaction Supports vendor communication by drafting emails or tracking responses. Tracks vendor deliverables and documentation; flags delays or issues to the project team; follows up on routine requests. Manages operational aspects of vendor relationships; participates in vendor selection discussions; reviews vendor performance metrics.

7How you'll be judged

The scoreboard, and what is not on it. The hard targets, how often each is actually looked at, and the quiet signals that never reach a dashboard.

TMF Completeness & Timeliness
The percentage of essential documents filed correctly and on time in the Trial Master File for your assigned studies.
Target · >95% completeness, <5% overdue documents

For Study X, you ensure 98% of all expected essential documents are filed within 14 days of receipt, with zero critical findings during the monthly TMF review.

Query Resolution Cycle Time
The average time it takes for site-related queries (e.g., TMF document queries, CTMS data queries) to be resolved.
Target · <5 business days average

You consistently resolve site queries in an average of 3 days, proactively chasing sites and internal teams to keep the clock ticking.

Site Activation Document Readiness
The percentage of sites for your assigned studies that have all essential documents (e.g., contracts, IRB approvals, 1572s) in place and approved before the Site Initiation Visit (SIV).
Target · 100% for all assigned sites

For the last three sites you supported, every single essential document was collected, QC'd, and filed correctly, allowing the SIV to proceed without a hitch.

System Data Accuracy
The error rate in data entry and updates within CTMS and other operational systems you manage.
Target · <2% error rate (e.g., site contact details, milestone dates)

During a recent CTMS data audit, only one minor discrepancy was found in 150 data points you managed, showing excellent attention to detail.

Proactive Issue Identification
How effectively you spot potential operational problems (e.g., upcoming document expirations, lagging site performance indicators) before they become critical.
  • You flag a site's GCP training expiry to the CRA a month in advance. You notice a trend of slow query responses from a particular CRO and bring it to your manager's attention. You suggest a better way to track a specific document type before an audit.
Stakeholder Communication & Collaboration
The clarity and effectiveness of your communication with internal teams and external site staff, and your ability to build good working relationships.
  • CRAs consistently praise your responsiveness and helpfulness. Site coordinators know they can come to you with questions. You provide clear, concise updates on documentation status to your project manager without being prompted.
Process Improvement Contributions
Your willingness and ability to identify inefficiencies in existing operational processes and propose practical solutions.
  • You suggest a small tweak to our TMF QC checklist that saves 15 minutes per review. You document a common system workaround to help others. You propose a new template for a recurring report that makes it clearer.
Inspection Readiness Mindset
Your consistent approach to maintaining documentation and processes as if an audit could happen tomorrow, ensuring everything is always 'inspection-ready'.
  • Your TMF sections are consistently well-organised and complete. You can quickly pull any requested document. You understand the 'why' behind regulatory requirements, not just the 'what'.

8Would you like it

Both sides. What people enjoy, and what grinds them down.

What people enjoy
Making a Tangible Difference in Healthcare

You'll feel a sense of purpose knowing that your meticulous work on documentation and processes directly supports clinical trials that could bring new treatments to patients. Every correctly filed document and resolved query moves us closer to that goal.

When you see a press release about a successful trial, you know your attention to detail played a part in making that data robust and reliable.

Achieving Operational Excellence

You'll get a real kick out of seeing a well-organised TMF, a perfectly reconciled CTMS, or a smooth site activation process. You thrive on efficiency, accuracy, and knowing that everything is 'inspection-ready'.

You're proud when your manager compliments the cleanliness and completeness of your assigned study's TMF during a quality review.

Problem Solving & Troubleshooting

You enjoy figuring out why a document isn't filing correctly, helping a site navigate a system issue, or finding the root cause of a data discrepancy. It's about bringing order to potential chaos.

A site calls with a complex EDC query, and after some digging and careful questioning, you guide them to the correct solution, saving them a lot of frustration.

What frustrates people
  • The endless document chase – constantly hounding sites for overdue paperwork.
  • Manual 'swivel chair' data entry across disconnected systems.
  • Dealing with vague protocol language that leads to operational confusion.
  • Having your carefully planned day completely upended by last-minute 'urgent' requests.
  • The sheer volume of trackers and spreadsheets you'll need to maintain, none of which are ever perfectly in sync.
What this role does not give you
  • A quiet, predictable 9-to-5 where every day is the same.
  • A role with minimal administrative burden or documentation.
  • Immediate, high-level strategic decision-making authority.
  • A 'set it and forget it' approach to tasks – everything needs ongoing vigilance.
  • A role where you rarely have to deal with demanding or disorganised external parties.

9Who you work with

You're directly responsible for the operational efficiency and compliance of our clinical trials. Your work ensures that critical study documents are accurate and complete, which is absolutely essential for regulatory submissions and successful inspections. Simply put, if you don't do your job well, our clinical programmes slow down, costing us time and money, and ultimately, delaying patient access to new therapies.

Inside the business
  • Clinical Project Managers
  • Clinical Research Associates (CRAs)
  • Data Management Team
  • Regulatory Affairs Team
  • Quality Assurance
Outside the business
  • Investigative Site Staff (Study Coordinators, Principal Investigators)
  • Contract Research Organisations (CROs)
  • Vendors (e.g., central labs, IRT providers)

10What you need before you start

Not a wish list. The things you would be expected to already have.

  • At least 2 years of experience in clinical operations, clinical research, or a closely related field, ideally within a pharmaceutical company, CRO, or academic research organisation.
  • Proven ability to manage and maintain detailed documentation, preferably within a regulated environment.
  • Demonstrable experience with at least one eTMF system (e.g., Veeva Vault, PhlexTMF) and one CTMS (e.g., Medidata Rave, Oracle Clinical One).
  • A solid understanding of the clinical trial lifecycle and key operational processes.
  • Excellent organisational skills and a meticulous approach to work, with a track record of catching errors before they become problems.

11What to practise next

Where the job is going, and what to do about it starting this week.

Advanced CTMS Configuration & Reporting

As studies become more complex and data needs grow, simply running pre-built reports won't cut it. You'll need to be able to pull more nuanced data and potentially configure study-specific settings to get the insights we need faster.

Custom Report Building · System Configuration Basics · Data Export & Manipulation

  • This month: Spend time exploring all the reporting functionalities in our current CTMS, even the ones you don't use daily.
  • Next quarter: Ask your manager or a senior colleague to walk you through how custom reports are built in the CTMS.
  • Within 6 months: Attempt to build one simple custom report in a test environment or with guidance, focusing on a specific operational metric.
  • Within 9 months: Take ownership of a recurring report, looking for ways to make it more efficient or insightful.

Quick win: Identify one piece of data you currently track manually that could potentially be pulled directly from the CTMS with a bit of digging.

Enhanced Data Visualisation for Operations

Just looking at raw numbers isn't enough. We need to quickly see trends, identify outliers, and communicate complex operational data clearly. Being able to build simple, effective dashboards will become a key skill.

Dashboard Design Principles · Connecting Data Sources · Key Operational Metrics Visualisation

  • This month: Explore public dashboards or examples of good data visualisation. Think about what makes them effective.
  • Next quarter: Take an introductory online course on Power BI or Tableau, focusing on basic chart types and dashboard creation.
  • Within 6 months: Try to recreate a simple operational report you currently use in Excel as a basic dashboard in Power BI/Tableau.
  • Within 9 months: Propose a new, simple dashboard to track a specific operational metric that isn't currently well-visualised.

Quick win: Use Excel's conditional formatting or sparklines to make one of your existing trackers more visually informative today.

12Staying current once you are in

What people here do to keep up
  • Attending industry webinars and conferences (e.g., DIA, SCOPE) to stay updated on new regulations, technologies, and best practices in clinical operations.
  • Joining professional organisations like ACRP or SOCRA for networking and access to resources.
  • Seeking out internal training opportunities on new systems or advanced features of existing ones (e.g., advanced CTMS reporting).
  • Participating in internal process improvement initiatives or working groups to gain exposure to broader operational challenges.
  • Mentoring junior staff or new joiners, even informally, to solidify your own understanding and develop leadership skills.

13The rising capability

The rising capability

Zavmo analysis

What's rising in its place

This is where the work is heading, and the higher pay with it. Get fluent here and the shift stops being a threat and starts being your edge.

AI-Assisted Document Review & QC

Our competitors are already using AI to automate initial TMF QC, flagging discrepancies and missing documents in minutes. If we don't adopt these tools, we'll be left behind, spending hours on manual checks that AI can do faster and more accurately.

  • Natural Language Processing (NLP)
  • Machine Learning for Classification
  • Anomaly Detection
  • Human-in-the-Loop Validation

Digital Literacy & Automation Mindset

The push for greater efficiency means more processes will be automated. You won't just follow a process; you'll need to understand how automation works and identify opportunities to simplify or automate tasks, even if you're not building the automation yourself.

  • Workflow Automation (e.g., RPA basics)
  • Data Integration Concepts
  • Low-Code/No-Code Platforms
  • Process Mapping

14What you’ll use

What you’ll use

Skills this role draws on

Technical

  • Good Clinical Practice (GCP)
  • TMF Management (DIA Reference Model)
  • Clinical Study Protocol Interpretation
  • Site Selection & Activation Support
  • Vendor & CRO Oversight (Operational)
  • Risk-Based Monitoring (RBM) Principles

15The pathway

The pathway

How you actually get there, here

How you become one varies far more by country than what one does. This is the UK route. Most people take one of these ways in; the right one depends on where you're starting from.

  1. 1

    Clinical Trial Assistant (CTA) or Associate Clinical Operations Specialist (L1)

    1-2 years

    Skills to master

    • Foundational GCP knowledge, basic eTMF/CTMS use, meticulous document management, understanding of study start-up documents.

    You're ready to move on when

    • Consistently accurate TMF filing and basic QC checks.
    • Reliable data entry and updates in CTMS.
    • Proactive in supporting CRAs with site document collection.
    • Can independently resolve simple system access issues for sites.
  2. 2

    Study Coordinator (Site-based)

    2-3 years

    Skills to master

    • Deep understanding of site operations, patient recruitment, protocol adherence, IRB submissions, and managing site-level essential documents.

    You're ready to move on when

    • Successfully managed multiple clinical trials at an investigative site.
    • Strong grasp of regulatory requirements from a site perspective.
    • Excellent communication with sponsors/CROs and internal site teams.
    • Experience with EDC systems and query resolution.
  3. 3

    Data Entry Specialist (Clinical Data Management)

    1-2 years

    Skills to master

    • Data quality, query management, understanding of clinical databases (EDC), attention to detail in data review.

    You're ready to move on when

    • Track record of high data accuracy and efficient query resolution.
    • Familiarity with EDC systems and data validation processes.
    • Understanding of data flow in clinical trials.
    • Strong organisational skills for managing data discrepancies.

16How people get here · where they go next

Came from
Clinical Trial Assistant (CTA) or Associate Clinical Operations Specialist (L1)
1-2 years
You mastered meticulous document management and basic quality control checks, laying the groundwork for your current role.
You are here
Clinical Operations Specialist
Mid-Level (2-5 years)
A Clinical Operations Specialist keeps clinical trials running smoothly, making sure paperwork, systems and sites are ready for patient enrolment.
Goes to
Senior Clinical Operations Specialist (L3)
3-5 years
This role involves leading initiatives, mentoring others, and tackling complex studies with greater autonomy.

The long view: This work can lead to lead operations roles overseeing complex studies, or into management, running a team of specialists.

The ten Future Fluencies

Zavmo analysis

The credential is what you can do today. These are what keep you valuable.

A qualification proves you can do the job as it's defined today. These ten are what decide whether you're still the obvious person for it in five years. They're the capabilities employers are now writing into senior roles faster than people are learning them. Zavmo weaves them through whatever you study, so you come out with both: the credential and the fluency.

The highlighted ones are the Fluencies your role leans on hardest, from how Clinical Operations Specialist is actually changing.

How you would learn this

One to one, on the work you already do

A tutor sets the task against your own job and marks the reasoning, at your pace. There is no cohort to fall behind.

A lesson from Conduct routine maintenance on clinical equipment, worked against Clinical Operations Specialist.

Conduct routine maintenance on clinical equipment Level 3

Applied to your work in Clinical Operations Specialist

This unit aims to provide learners with the knowledge and skills to conduct routine maintenance on clinical equipment, ensuring compliance with relevant legislation, guidelines, policies, and protocols. Learners will understand the necessary procedures, safety precautions, and documentation requirements for effective equipment maintenance. Upon completion, learners will be able to prepare for and carry out routine maintenance tasks safely and effectively.

The Navigator Last time, we explored how AI can assist with TMF quality control. How did you find using AI tools for document review?

You It was interesting, but I'm still figuring out the best way to integrate them into my routine.

The Navigator Why not start by identifying one specific document review task you do regularly and see how an AI tool could streamline it? We can discuss your findings next time.

How the thinking builds
  1. 1 Remember
  2. 2 Understand
  3. 3 Apply
  4. 4 Analyse
  5. 5 Evaluate
  6. 6 Create
An illustration of a Zavmo lesson, built from this role’s own route. The unit, its objective and every criterion above are the awarding body’s own words, not an example.

It is £70 a month, billed monthly. Your free first module is Future Fluency, and you can cancel any time.

A year from now

A year from now, you are a confident Clinical Operations Specialist who leverages AI to enhance efficiency while honing your strategic thinking and leadership skills.

See Your Progress Grow Illustration
Clinical Operations Specialist
  • Good Clinical Practice (GCP)
  • TMF Management (DIA Reference Model)
  • Clinical Study Protocol Interpretation
  • Site Selection & Activation Support
  • Vendor & CRO Oversight (Operational)
  • Risk-Based Monitoring (RBM) Principles
This is your Mind Palace on learn.zavmo.ai. Every skill above comes from this role's own record, not an example borrowed from another job. A node lights up when you evidence it, and what you build stays yours between jobs. That is the part a course cannot do.

17The detail, folded away

Everything else the record holds

The career branches in full, how AI is already showing up in the day-to-day, and the questions people ask about this job. Here when you want them, out of the way while you decide.

Where it leads next, rung by rung

Where it leads

The career path, and where it branches

Clinical Operations Specialist is a start, not a ceiling. Each step below asks for new skills and hands back more autonomy.

  1. Senior Clinical Operations Specialist (L3)

    3-5 years in current role

    You'll move from owning processes to leading initiatives and mentoring others. You'll take on more complex studies and have greater autonomy.

    • Designing & Implementing Operational Processes Not just following, but improving and creating.
    • Vendor Performance Review More active role in assessing and managing vendor deliverables.
    • Advanced TMF Strategy Contributing to TMF plan development for complex studies.
    • Risk Mitigation Planning Identifying and planning for operational risks proactively.
Working with AI on the job

Working with AI

Where AI is starting to help

Clinical Operations is ripe for AI. Imagine spending less time on tedious document checks and more time on strategic problem-solving. Our AI Productivity Hub is packed with tools that can help you do just that.

Let's be real, a big chunk of your day is spent on repetitive, administrative tasks. Our AI tools aren't here to replace you, but to give you back precious hours. Think of them as super-efficient personal assistants, handling the grunt work so you can focus on what actually matters.

TMF Document Auto-Classification

AI reads newly uploaded documents (CVs, lab certificates, IRB letters), figures out what they are, pulls out key details like dates and names, and suggests exactly where they should live in the TMF based on the DIA model. No more manual sorting or tagging!

Intelligent Site Feasibility

An AI assistant scans trial registries, academic papers, and investigator databases to generate a ranked shortlist of potential high-performing sites for a new protocol. It's tailored to your specific inclusion/exclusion criteria, saving you hours of manual research.

Protocol Deviation Summarisation

AI reviews logged protocol deviations, categorises them by type (e.g., consent, procedural), identifies trends across sites, and even drafts narrative summaries for annual reports and regulatory submissions. This means less time writing and more time analysing.

Automated Query Response Drafting

For common site queries about system access or basic documentation, AI can draft initial responses based on our knowledge base and FAQs. You'll review and send, saving you time on repetitive email writing and ensuring consistent answers.

Common questions

Common questions

How do you become a Clinical Operations Specialist?

Common routes in include Clinical Trial Assistant (CTA) or Associate Clinical Operations Specialist (1-2 years), Study Coordinator (Site-based) (2-3 years) and Data Entry Specialist (Clinical Data Management) (1-2 years). Times vary with prior experience.

Where can a Clinical Operations Specialist progress to?

This role can lead on to Senior Clinical Operations Specialist (3-5 years in current role), depending on the skills you build.

What new skills matter most for a Clinical Operations Specialist?

Increasingly, AI-Assisted Document Review & QC and Digital Literacy & Automation Mindset. These are the skills our record of this role lists as growing.

Free tools

Want a read on where you stand?

Three free tools, no account needed. Each one ends with a role, a level and a way in.

18Where to go from here

Other roles at Level 3

Same depth of qualification, different job. Useful if the work appeals but this particular role does not.

More jobs in operations

Stay in the field you know and move sideways rather than up.

If you leave this industry

The skills involved are transferable. This work can lead into Clinical Project Management, Clinical Quality Assurance, Regulatory Affairs Operations, or a specialist role at a Contract Research Organisation or clinical technology vendor. Operational expertise like this applies across clinical research.

This role profile is © 2026 Growth Engineering Technologies Ltd. Built from UK occupational standards and regulated qualification data, and written for Zavmo.

You're not behind. You're right on time. The shift is only just beginning. Your role won't look the same in two years. Be the one who leads the change, not the one it happens to. Start my Clinical Operations Specialist plan, free What happens next: a free account, then we build your plan as you set up. No card. Build your plan, see your roadmap and meet the twelve tutors matched to you. All free. When you're ready to start learning, it's £70 a month, billed monthly. Cancel any time and billing stops.