At a Glance
- Tasks: Manage clinical trials and oversee regulatory compliance in a dynamic research environment.
- Company: Join a well-funded international research programme focused on innovative health technologies.
- Benefits: Enjoy 30 days annual leave, generous pension, and paid volunteering days.
- Other info: Opportunity for career growth and mentorship in a collaborative setting.
- Why this job: Make a real impact in clinical research while working with cutting-edge technology.
- Qualifications: Strong clinical trial management experience and knowledge of regulatory submissions required.
The predicted salary is between 63000 - 63000 £ per year.
An exciting opportunity has arisen for an experienced Clinical Trial Manager to join a highly ambitious, well-funded international research programme focused on clinical trials, digital health, AI, wearable technology and population health. This is a senior, hands-on role suited to someone who wants to operate beyond traditional site delivery. The successful candidate will support the operational delivery and regulatory oversight of clinical trials, including observational and interventional sub-studies, while helping to build the governance, quality and regulatory infrastructure required for a complex multi-partner research programme.
The role will involve managing day-to-day trial operations, supporting study set-up, overseeing site feasibility, activation and close-out, maintaining TMF/eTMF documentation, monitoring recruitment and retention, ensuring data quality and compliance, and working closely with academic, clinical, commercial and regulatory stakeholders.
A key part of the position will be preparing and submitting regulatory and ethics applications, supporting audit and inspection readiness, contributing to SOP and QMS development, and ensuring trials are delivered in line with GCP, GDPR and relevant regulatory requirements.
Key responsibilities include:
- Managing day-to-day clinical trial operations across observational and interventional studies
- Supporting site feasibility, selection, initiation, monitoring oversight and close-out
- Preparing and submitting regulatory and ethics applications, amendments and progress reports
- Maintaining TMF/eTMF documentation and version control
- Monitoring recruitment, retention, protocol compliance and trial performance
- Supporting implementation and use of EDC and mobile data capture platforms
- Ensuring data integrity, privacy, GDPR compliance and inspection readiness
- Developing and maintaining SOPs, trial processes and quality frameworks
- Coordinating communication between academic teams, clinical sites, partners and regulatory bodies
- Supporting trial budgets, reporting, governance meetings and stakeholder updates
- Supervising or mentoring junior clinical research staff as the programme grows
Essential experience:
- Strong clinical trial management experience
- Experience across the full trial lifecycle, from set-up to delivery and close-out
- Hands-on experience with regulatory and ethics submissions, such as MHRA, REC or international equivalents
- Strong understanding of GCP, clinical trial governance and regulatory compliance
- Experience managing TMF/eTMF documentation and essential study files
- Experience with site set-up, monitoring oversight, recruitment tracking and compliance
- Strong IT and data management skills, including EDC or CTMS platforms
- Experience developing or maintaining SOPs, work instructions or quality processes
- Ability to work effectively across academic, clinical, commercial and regulatory stakeholders
Desirable experience:
- Academic, NHS, university, sponsor-side or investigator-led trial experience
- Experience in multi-site or international clinical research programmes
- Exposure to digital health, remote trials, wearable technology, AI-enabled studies or MedTech
- Experience contributing to QMS development or inspection readiness
- Experience in population health, maternal health, paediatrics or digital clinical studies
- Experience mentoring or managing junior clinical research staff
This is a fantastic opportunity for a Clinical Trial Manager who wants to step into a broader programme-level role with genuine ownership across clinical operations, regulatory submissions, governance and quality.
To find out more, please apply or get in touch directly.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Clinical & Regulatory Programme Manager in London
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Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for the Senior Clinical & Regulatory Programme Manager at BioTalent, focus on highlighting your clinical experience and any specific training you've undergone. Include any relevant placements or internships you’ve completed, as well as any certifications that bolster your qualifications in human medicine.
Highlight Your Soft Skills:In the field of human medicine, soft skills are just as crucial as technical knowledge. Mention your communication skills, empathy, and teamwork experiences in your CV and cover letter. This shows that you can work well in a clinical setting and with patients, which is super important in this industry!
Tailor Your Cover Letter Thoughtfully:Be sure to personalise your cover letter for the Senior Clinical & Regulatory Programme Manager at BioTalent. Mention why you’re passionate about human medicine and how you align with the company’s mission. This is your chance to convey your enthusiasm and make a case for why you'll be a valuable addition to the team!
Include Continuing Education:Make sure to mention any ongoing education or courses you’re taking to keep your skills sharp. In human medicine, staying updated with the latest practices is key. It shows you’re dedicated to your field, which employers like BioTalent will definitely appreciate!
How to prepare for a job interview at BioTalent
✨Brush Up on Clinical Knowledge
Since you're aiming for a role in human medicine, make sure you’re sharp on the latest clinical guidelines and practices relevant to the position. Be prepared to discuss case studies or scenarios you might encounter in the role. This will show that you're not just knowledgeable but also ready to apply that knowledge in real-life situations.
✨Demonstrate Soft Skills
In human medicine, technical skills are crucial, but don’t forget to showcase your soft skills like communication, empathy, and teamwork. In your answers, share specific examples of how you've worked effectively with patients or colleagues in the past, as these traits are highly valued in clinical settings.
✨Know Your CV Backwards
As you’re applying for a full-time position, your CV should tell a story. Be ready to discuss every part of it, especially your clinical experiences, the impact you had, and what you learned. Employers want to see how your journey has prepared you for this role, so think of it like you're taking them through your professional narrative.
✨Prepare for Ethical Scenarios
Ethics are a big deal in human medicine, so expect questions that assess your decision-making in tricky situations. Think about how you'd handle ethical dilemmas or patient confidentiality concerns. Prepare a few examples that illustrate your thought process and how you prioritise patient welfare in your decision-making.
