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For Companies At a Glance
- Tasks: Lead clinical performance studies and manage documentation for ALBA products.
- Company: Join a leading company in the diagnostics and life sciences industry.
- Benefits: Enjoy a competitive salary, great benefits, and opportunities for professional development.
- Other info: Flexible work environment with opportunities for continuous improvement and innovation.
- Why this job: Be part of innovative projects that impact healthcare and collaborate with diverse teams.
- Qualifications: Relevant degree in a scientific field and experience in clinical study activities required.
The predicted salary is between 36000 - 60000 £ per year.
- Midlothian
- Great role
About Our Client
A leader in their field
Job Description
Lead the design, planning and management of clinical performance studies for ALBA products, ensuring alignment with regulatory expectations and departmental priorities. Demonstrates accountability by delivering high-quality outcomes and meeting study timelines.
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Develop, review and maintain study documentation including clinical protocols, data analysis plans, case report forms (CRFs), clinical study reports and associated technical records in accordance with GCP and all other applicable guidance – instilling trust in the scientific evidence base.
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Analyse clinical study data and generate summary reports, applying rigorous scientific methodology and attention to detail. Collaborates with internal and external stakeholders to ensure results are clearly presented and support regulatory needs.
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Coordinate and manage communication with external collaborators, such as study sites or partner organisations and internal stakeholders including Regulatory Affairs, Quality and R&D – building effective teams to achieve shared study goals.
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Review and update scientific validity documentation to ensure alignment with the latest regulatory guidance and scientific literature, maintaining a current and defensible rationale for the intended use of ALBA products.
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Support IVDR compliance activities, including responding to queries, supporting technical documentation reviews and ensuring clinical evidence files remain audit-ready and scientifically sound.
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Contribute to the development and revision of Instructions for Use (IFU) for both new and existing products, ensuring content reflects accurate clinical and technical information and aligns with regulatory requirements – delivering customer-orientated solutions.
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Assist in preparing for regulatory inspections or notified body reviews related to clinical evidence and documentation, demonstrating responsibility and commitment to compliance.
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Support laboratory activities related to clinical studies, if qualified, including sample logistics, instrument coordination or limited hands-on testing as needed, demonstrating flexibility and teamwork.
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Promote continuous improvement and innovation by identifying areas for process optimisation and sharing insights to improve clinical study operations and evidence generation practices.
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Actively participate in departmental meetings, knowledge sharing and training, cultivating innovation and contributing to the professional development of self and others.
The Successful Applicant
Relevant degree or equivalent qualification in a scientific or health-related discipline (e.g., Biomedical Science, Biochemistry, Biology or a field with a strong emphasis on clinical research).
Demonstrated experience supporting or leading clinical study activities within the diagnostics or life sciences industry.
Familiarity with GCP, ISO 14155, IVDR and relevant clinical study standards
Strong written and verbal communication skills, including experience preparing clinical study documentation.
Proficiency with Microsoft Office tools (Word, Excel, Outlook, Powerpoint).
Understanding of data handling, statistical analysis approaches and good documentation practices.
What\’s on Offer
A competitive salary and great benefits
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Clinical Affairs Associate employer: Michael Page (UK)
Contact Detail:
Michael Page (UK) Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Affairs Associate
✨Tip Number 1
Familiarise yourself with the latest regulatory guidelines, especially GCP and IVDR. This knowledge will not only help you in interviews but also demonstrate your commitment to compliance and quality in clinical studies.
✨Tip Number 2
Network with professionals in the diagnostics and life sciences industry. Attend relevant conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in clinical research.
✨Tip Number 3
Prepare to discuss specific examples of how you've contributed to clinical study activities in the past. Highlight your experience with data analysis and documentation, as these are crucial for the role.
✨Tip Number 4
Showcase your proficiency with Microsoft Office tools by being ready to discuss how you've used them in previous roles. Being able to present data clearly and effectively is key in this position.
We think you need these skills to ace Clinical Affairs Associate
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in clinical study activities, particularly within the diagnostics or life sciences industry. Emphasise your familiarity with GCP, ISO 14155, and IVDR standards.
Craft a Strong Cover Letter: In your cover letter, express your passion for clinical research and detail how your background aligns with the responsibilities of the Clinical Affairs Associate role. Mention specific experiences that demonstrate your ability to manage clinical performance studies.
Showcase Communication Skills: Since strong written and verbal communication skills are essential, include examples of how you've effectively communicated complex information in previous roles. This could be through preparing clinical study documentation or collaborating with stakeholders.
Highlight Continuous Improvement Initiatives: Discuss any past experiences where you identified areas for process optimisation in clinical study operations. This shows your commitment to innovation and improvement, which is valued in this role.
How to prepare for a job interview at Michael Page (UK)
✨Know Your Regulations
Familiarise yourself with GCP, ISO 14155, and IVDR regulations. Being able to discuss these standards confidently will show your understanding of the clinical research landscape and demonstrate that you are prepared for the role.
✨Showcase Your Analytical Skills
Prepare to discuss your experience with data analysis and how you've applied rigorous scientific methodology in past projects. Be ready to provide examples of how you've generated summary reports and presented findings to stakeholders.
✨Communication is Key
Highlight your strong written and verbal communication skills. Be prepared to discuss how you've coordinated with internal and external stakeholders in previous roles, ensuring clarity and alignment on study goals.
✨Demonstrate Teamwork and Flexibility
Share examples of how you've worked collaboratively in a team environment, especially in clinical settings. Discuss any experiences where you've had to adapt to changing circumstances or support laboratory activities related to clinical studies.