National AI Awards 2025Discover AI's trailblazers! Join us to celebrate innovation and nominate industry leaders.

Nominate & Attend

Clinical Trial Lead

The RFT Group
Southampton
5 days ago
Create job alert

Clinical Trial Lead, Biopharma

Our client, a Biopharma company, now seek 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 majority of 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)


For further details, please contactLarry on +353 1 – 2302400 /


The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.www.rftgroup.ie

Related Jobs

View all jobs

Clinical Trial Lead

Clinical Trial Lead

Clinical Trial Lead

Clinical Trial Lead

Clinical Trial Lead

Clinical Trial Lead

National AI Awards 2025

Subscribe to Future Tech Insights for the latest jobs & insights, direct to your inbox.

By subscribing, you agree to our privacy policy and terms of service.

Industry Insights

Discover insightful articles, industry insights, expert tips, and curated resources.

How to Get a Better Biotechnology Job After a Lay-Off or Redundancy

Being made redundant from a biotechnology role can come as a shock, especially when your work involves complex research, innovation, and long development cycles. Whether due to funding cuts, mergers, shifting priorities in pharma or medtech, or economic turbulence, redundancies in biotech are becoming more common. But this doesn’t have to be the end of your career trajectory. In fact, many professionals go on to find better, more rewarding roles after a redundancy. With the UK’s biotech sector still growing rapidly across life sciences, pharmaceuticals, diagnostics, biomanufacturing, and synthetic biology, new opportunities are emerging every day. This guide will help you bounce back with purpose. From mental reset and CV refresh to recruiter outreach and sector-specific job search tips, here’s how to turn redundancy into a career upgrade.

Biotech Jobs Salary Calculator 2025: Pinpoint Your True Worth in the UK Life‑Sciences Market

Why yesterday’s salary guide won’t cut it in today’s biotech landscape “Could I earn more elsewhere?” Every life‑sciences professional has whispered that question—perhaps after seeing a colleague jump to a new start‑up for a chunky raise, or hearing that a peer at a rival pharma company pocketed a surprise bonus. Yet finding a credible benchmark in biotechnology is harder than ever. The sector morphs daily: gene‑therapy breakthroughs spawn new manufacturing lines, government funds pour into north‑of‑England cell‑&‑gene hubs, & Covid‑era mRNA expertise now permeates vaccine, oncology, & even agritech pipelines. Pay bands move with each development; a salary survey printed last year is already a museum piece. To clear the fog, BiotechnologyJobs.co.uk has reverse‑engineered a straightforward, three‑factor formula that estimates an accurate 2025 salary for UK‑based biotech professionals in seconds. Feed in your role, your region, & your seniority, and you’ll have a solid figure to anchor your next pay review or job‑offer negotiation. This article spells out the formula, spotlights the forces driving wages upward, & lays out practical steps to boost your market value over the next 90 days.

How to Present Biotech Concepts to Non-Scientists: A Public Speaking Guide for Job Seekers

In today’s biotechnology job market, your ability to explain complex science clearly is just as important as your lab skills. Whether you're applying for a research role, pitching to investors, or collaborating with marketing teams, you'll often need to present technical information to people without a scientific background. This blog explores how biotechnology job seekers can develop and deliver compelling presentations that make sense to non-scientists. From structuring your content to designing effective slides and using storytelling to bring data to life, these techniques will help you stand out in interviews and on the job.