Clinical Trial Lead

Clinical Trial Lead

Full-Time 48000 - 72000 £ / year (est.) No home office possible
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At a Glance

  • Tasks: Lead site management for Phase II and III clinical trials, ensuring compliance and performance.
  • Company: Join a leading Biopharma company focused on innovative clinical research.
  • Benefits: Enjoy flexible remote work options and opportunities for international travel.
  • Why this job: Make a real impact in healthcare while working with diverse teams across the globe.
  • Qualifications: 5 years of clinical research experience and a relevant degree are essential.
  • Other info: Mentorship opportunities available; ideal for those passionate about advancing medical science.

The predicted salary is between 48000 - 72000 £ per year.

Our client, a Biopharma company, now seeks a Clinical Trial Lead working as part of the Clinical Operations team and with internal functions (e.g. Data Management, Clinical Research, QA, Reg Affairs, etc.) and working externally providing support for oversight of CROs and other vendors. This hire will be based in the UK or Ireland and have flexibility to work the majority of the time from their home office, with some office presence and travel as required.

This hire will lead site management activities and support the Lead Clinical Project Manager (CPM) on Phase II and III Clinical trials across the UK, EU, US, etc. Serving as the primary day-to-day contact for their CRO counterpart (i.e. CTMs, CRAs), and clinical site staff; and supporting the Lead CPM as required. The successful candidate will lead and coordinate all aspects of site management, from feasibility and site identification through to close-out, including selection, initiation, monitoring, and issue resolution, in close partnership with the CRO.

The ideal candidate will have 5 years Clinical Research experience; progressing from CRA I, II, Senior CRA / Lead CRA, or CTM. Clinical Trial Management experience is preferred, on late-stage Clinical trials (i.e. II and III), to ICH-GCP, MHRA, EMA and FDA guidelines.

Responsibilities:
  • Review CRA visit reports to ensure monitoring activities are conducted per the monitoring plan.
  • Monitor site performance metrics (e.g., patient screening/ recruitment, protocol deviations, DM queries etc.) and help identify at-risk sites.
  • Support timely resolution of site-level issues through proactive communication and follow-up.
  • Ensure site compliance and performance through close collaboration with CRAs and site personnel.
  • Oversee adherence to protocol, regulatory requirements, and quality standards at the site level.
  • Track actual vs. planned patient recruitment, report variances, and implement contingencies in consultation with senior management.
  • Monitor and report clinical study metrics and KPIs to ensure timeline and deliverable compliance, escalating unresolved issues to the CPM as appropriate.
  • Support Lead CPM in the planning and execution of operational meetings, CRO/vendor kick-offs, Investigator Meetings, CRA trainings, and site visits (selection, initiation, motivational and monitoring oversight).
  • Assist in preparing and maintaining essential study documents (e.g., protocols, ICFs, monitoring plans, trial management plans).
  • Support the implementation of quality, audit, and risk management plans; ensure corrective actions from audits are completed.
  • Ensure all trial activities comply with ICH-GCP, FDA, EMA, MHRA, and local regulatory guidelines.
  • Support inspection readiness efforts and contribute to clinical audits or regulatory inspections as required.
  • Provide guidance and mentorship to clinical operations staff and act as a resource on site-related matters.
Requirements:
  • Bachelor’s degree in life sciences, nursing, pharmacy, or a related field.
  • 5 years of experience in clinical research progressing from CRA to CRA II, Senior CRA / Lead CRA to experienced Clinical Trial Manager / Clinical Trial Lead or equivalent role.
  • Direct experience managing Phase II and III trials across the UK, EU, US, and UK is an advantage.
  • Demonstrated ability to manage multiple sites and vendors in a global clinical environment.
  • Proficient with clinical trial systems such as CTMS, EDC, IRT/IWRS, eCOA, and eTMF.
  • Strong knowledge of ICH-GCP and relevant regulatory frameworks (FDA, EMA, MHRA).
  • Proven ability to successfully achieve results within a multi-cultural and geographically diverse cross-functional team.
  • Excellent leadership, organizational, and interpersonal skills.
  • Fluent in English (spoken and written).
  • Some international travel will be required (mainly the UK, Europe, US).

Clinical Trial Lead employer: The RFT Group

As a leading Biopharma company, we pride ourselves on fostering a collaborative and innovative work environment that empowers our Clinical Trial Leads to excel in their roles. With the flexibility to work from home and a strong emphasis on employee growth through mentorship and training, we ensure our team members are well-supported in managing complex clinical trials across multiple regions. Join us to be part of a dynamic team that values quality, compliance, and the advancement of healthcare solutions.
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Contact Detail:

The RFT Group Recruiting Team

StudySmarter Expert Advice 🤫

We think this is how you could land Clinical Trial Lead

✨Tip Number 1

Network with professionals in the biopharma industry, especially those who have experience as Clinical Trial Leads or in similar roles. Attend industry conferences and webinars to connect with potential colleagues and learn about the latest trends in clinical trials.

✨Tip Number 2

Familiarise yourself with the specific regulatory guidelines relevant to the role, such as ICH-GCP, MHRA, EMA, and FDA. Being well-versed in these regulations will not only boost your confidence but also demonstrate your commitment to compliance during interviews.

✨Tip Number 3

Prepare to discuss your experience managing Phase II and III trials in detail. Be ready to share specific examples of how you've handled site management activities, resolved issues, and collaborated with CROs and other vendors.

✨Tip Number 4

Showcase your leadership and interpersonal skills by preparing anecdotes that highlight your ability to work within diverse teams. Emphasise your experience in mentoring others and how you’ve contributed to a positive team environment in previous roles.

We think you need these skills to ace Clinical Trial Lead

Clinical Research Experience
Site Management
Knowledge of ICH-GCP
Regulatory Compliance (FDA, EMA, MHRA)
Clinical Trial Management
Vendor Management
Monitoring and Issue Resolution
Patient Recruitment Strategies
Data Management Systems (CTMS, EDC, IRT/IWRS, eCOA, eTMF)
Leadership Skills
Organisational Skills
Interpersonal Skills
Communication Skills
Problem-Solving Skills
Ability to Work in a Multi-Cultural Environment

Some tips for your application 🫡

Tailor Your CV: Make sure your CV highlights relevant experience in clinical research, particularly your progression from CRA roles to Clinical Trial Manager. Emphasise your familiarity with Phase II and III trials and any specific regulatory knowledge you possess.

Craft a Compelling Cover Letter: In your cover letter, express your enthusiasm for the role and the company. Mention specific experiences that align with the responsibilities listed in the job description, such as managing site performance metrics or overseeing compliance with ICH-GCP guidelines.

Showcase Leadership Skills: Since the role requires strong leadership and interpersonal skills, provide examples of how you've successfully led teams or projects in your previous roles. Highlight any mentorship experiences or cross-functional collaborations.

Proofread and Edit: Before submitting your application, thoroughly proofread your documents for any spelling or grammatical errors. A polished application reflects attention to detail, which is crucial in clinical trial management.

How to prepare for a job interview at The RFT Group

✨Know Your Clinical Research Fundamentals

Make sure you brush up on your knowledge of ICH-GCP, FDA, EMA, and MHRA guidelines. Being able to discuss these regulations confidently will show that you understand the framework within which clinical trials operate.

✨Demonstrate Leadership Skills

As a Clinical Trial Lead, you'll need to showcase your leadership abilities. Prepare examples from your past experiences where you've successfully led teams or managed multiple sites, highlighting your organisational and interpersonal skills.

✨Familiarise Yourself with the Company

Research the biopharma company you're interviewing with. Understand their pipeline, recent studies, and any challenges they may be facing. This will help you tailor your responses and demonstrate your genuine interest in their work.

✨Prepare for Scenario-Based Questions

Expect questions that assess your problem-solving skills in real-world scenarios. Think about potential site-level issues you might encounter and how you would resolve them, as well as how you would ensure compliance and performance across sites.

Clinical Trial Lead
The RFT Group
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  • Clinical Trial Lead

    Full-Time
    48000 - 72000 £ / year (est.)

    Application deadline: 2027-07-20

  • T

    The RFT Group

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