Senior Clinical & Regulatory Programme Manager

Senior Clinical & Regulatory Programme Manager

Full-Time 63000 - 63000 £ / year (est.) No working from home possible
BioTalent

At a Glance

  • Tasks: Lead clinical trials and ensure regulatory compliance while managing day-to-day operations.
  • Company: Join a dynamic international research programme focused on digital health and AI.
  • Benefits: Enjoy 30 days annual leave, generous pension, and paid volunteering days.
  • Other info: Opportunity for career growth and mentoring junior staff in a collaborative environment.
  • Why this job: Make a real impact in innovative clinical research and technology.
  • Qualifications: Strong clinical trial management experience and regulatory submission skills required.

The predicted salary is between 63000 - 63000 £ per year.

  • Clinical
  • Trial
  • Manager

Location: London, UK Salary: up to £63,000 Contract: 3-year fixed term with renewal Benefits include:

  • 30 days annual leave
  • 4 additional concessionary days between Christmas and New Year
  • Bank holidays
  • Generous pension scheme
  • 3 paid volunteering days per year
  • Discount programme
  • Travel, cycle and car schemes 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/e TMF 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/e TMF 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/e TMF 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 Med Tech
  • 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.

BioTalent

Contact Details:

BioTalent Recruitment Team

We think you need these skills to ace Senior Clinical & Regulatory Programme Manager

Clinical Trial Management
Regulatory Submissions
GCP Compliance
TMF/eTMF Documentation Management
Site Feasibility and Selection
Data Integrity and Privacy
EDC and CTMS Platforms