At a Glance
- Tasks: Support clinical studies and ensure compliance with regulatory standards in a dynamic environment.
- Company: Fast-evolving IVD company based in Scotland with a collaborative culture.
- Benefits: Hybrid working model, competitive salary, and opportunities for professional growth.
- Why this job: Step into a strategic role and make a real impact in the diagnostics field.
- Qualifications: Experience in clinical research and strong communication skills required.
- Other info: Join a team that values innovation and offers excellent career advancement opportunities.
The predicted salary is between 36000 - 60000 Β£ per year.
Are you looking to step out of site monitoring and into a more strategic, cross-functional clinical role? An established and fast-evolving IVD company based in Scotland is seeking a Clinical Affairs Associate to support clinical performance studies, regulatory documentation, and IVDR compliance for a market-leading diagnostic product portfolio.
This is a unique opportunity for someone with a background in clinical research, such as a CRA or Clinical Study Associate, who is looking to move into a broader, more collaborative role β working closely with Regulatory Affairs, R&D, and Quality teams.
- Plan, manage and support clinical performance studies in line with GCP and IVDR requirements
- Develop clinical protocols, data analysis plans, CRFs and study reports
- Contribute to scientific validity reports and Instructions for Use (IFUs)
- Collaborate with external partners and internal teams (Regulatory, QA, R&D)
- Ensure clinical documentation is audit-ready and aligned with EU regulatory standards
- Support technical documentation reviews and process improvements
Experience supporting or leading clinical study activities (CRA, CTA, Clinical Affairs, etc.)
Solid understanding of GCP, ISO 14155 and IVDR or EU regulatory frameworks
Excellent written communication and documentation skills
Organised, analytical, and comfortable working cross-functionally
Looking to move away from field-based roles into strategic office-based work
Based in Scotland
Hybrid working (2β3 days onsite)
Clinical Affairs Associate in London employer: CPL
Contact Detail:
CPL Recruiting Team
StudySmarter Expert Advice π€«
We think this is how you could land Clinical Affairs Associate in London
β¨Tip Number 1
Network like a pro! Reach out to your connections in the clinical research field and let them know you're on the lookout for a Clinical Affairs Associate role. You never know who might have the inside scoop on job openings or can put in a good word for you.
β¨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GCP, ISO 14155, and IVDR regulations. Be ready to discuss how your past experiences as a CRA or Clinical Study Associate can translate into this new strategic role. Confidence is key!
β¨Tip Number 3
Showcase your collaborative spirit! During interviews, highlight examples of how you've worked cross-functionally with teams like Regulatory Affairs, R&D, and Quality. This will demonstrate that you're not just a lone wolf but a team player ready to contribute.
β¨Tip Number 4
Don't forget to apply through our website! Itβs the best way to ensure your application gets noticed. Plus, we love seeing familiar faces from our community, so make sure to let us know you're interested in joining the team!
We think you need these skills to ace Clinical Affairs Associate in London
Some tips for your application π«‘
Tailor Your Application: Make sure to customise your CV and cover letter for the Clinical Affairs Associate role. Highlight your experience in clinical research and any relevant skills that align with the job description, like GCP and IVDR knowledge.
Showcase Your Collaboration Skills: Since this role involves working closely with various teams, emphasise your ability to collaborate effectively. Share examples of past experiences where youβve worked cross-functionally, especially in clinical settings.
Be Clear and Concise: When writing your application, keep it clear and to the point. Use straightforward language to demonstrate your excellent written communication skills, as this is crucial for the role.
Apply Through Our Website: We encourage you to apply directly through our website. Itβs the best way to ensure your application gets seen by the right people and shows your enthusiasm for joining our team!
How to prepare for a job interview at CPL
β¨Know Your Regulations
Familiarise yourself with GCP, ISO 14155, and IVDR regulations. Being able to discuss these frameworks confidently will show that you understand the compliance landscape and are ready to contribute to the team.
β¨Showcase Your Collaboration Skills
Prepare examples of how you've worked cross-functionally in previous roles. Highlighting your experience collaborating with Regulatory Affairs, R&D, and Quality teams will demonstrate your ability to thrive in a strategic role.
β¨Be Ready to Discuss Clinical Protocols
Brush up on your knowledge of developing clinical protocols and data analysis plans. Be prepared to discuss any relevant experiences where you contributed to study reports or scientific validity reports.
β¨Organised and Analytical Mindset
Emphasise your organisational skills and analytical thinking during the interview. Share specific instances where your attention to detail ensured audit-ready documentation or improved processes in past projects.