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- 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.
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 contact Larry 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.
Clinical Trial Lead employer: The RFT Group
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 seminars to meet potential colleagues and learn about the latest trends in clinical trials.
✨Tip Number 2
Familiarise yourself with the specific clinical trial systems mentioned in the job description, such as CTMS and EDC. Having hands-on experience or certifications in these systems can set you apart from other candidates.
✨Tip Number 3
Demonstrate your leadership skills by sharing examples of how you've successfully managed teams or projects in previous roles. Highlight any experience you have in mentoring junior staff or leading cross-functional teams.
✨Tip Number 4
Stay updated on regulatory guidelines like ICH-GCP, FDA, EMA, and MHRA. Consider taking refresher courses or attending workshops to ensure you're well-versed in compliance, as this is crucial for the role.
We think you need these skills to ace Clinical Trial Lead
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 or Lead. Emphasise your experience with Phase II and III trials and any specific regulatory knowledge you possess.
Craft a Compelling Cover Letter: In your cover letter, explain why you're passionate about clinical trials and how your background aligns with the responsibilities of the Clinical Trial Lead role. Mention your experience with CROs and site management, and how you can contribute to the company's success.
Highlight Key Skills: Ensure you mention key skills such as leadership, organisational abilities, and proficiency with clinical trial systems. Provide examples of how you've successfully managed multiple sites and vendors in previous roles.
Proofread Your Application: Before submitting, carefully proofread your application for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial in clinical research.
How to prepare for a job interview at The RFT Group
✨Know Your Clinical Trials
Make sure you have a solid understanding of Phase II and III clinical trials, especially in relation to ICH-GCP, MHRA, EMA, and FDA guidelines. Be prepared to discuss your previous experiences managing these trials and how you handled challenges.
✨Demonstrate Leadership Skills
As a Clinical Trial Lead, you'll need to showcase your leadership abilities. Prepare examples of how you've successfully led teams, managed multiple sites, and resolved conflicts in a clinical setting.
✨Familiarise Yourself with CROs
Since you'll be working closely with CROs, it's essential to understand their role in clinical trials. Be ready to discuss how you've collaborated with CROs in the past and how you ensure compliance and performance at the site level.
✨Prepare for Scenario Questions
Expect scenario-based questions that assess your problem-solving skills. Think about potential issues that could arise during a trial and how you would address them, particularly regarding patient recruitment and site performance metrics.
