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- Tasks: Lead and manage clinical performance evaluation studies in IVD and immunoassays.
- Company: Dynamic diagnostics company at the forefront of innovation and quality.
- Benefits: Competitive salary, hybrid work model, and opportunities for professional growth.
- Why this job: Make a real impact on patient diagnostics and shape clinical strategy.
- Qualifications: Degree in Life Sciences or Medicine; experience in clinical research required.
- Other info: Join a progressive team dedicated to innovation and patient benefit.
The predicted salary is between 36000 - 60000 £ per year.
A dynamic company operating at the forefront of In Vitro Diagnostic (IVD) immunoassay development has an exciting opening for a Clinical Evaluation Performance Lead. This is a senior, hands-on role with strategic responsibility for the design, delivery, and oversight of clinical performance evaluation studies in line with IVDR (2017/746), FDA, and international regulatory requirements. This position will suit an experienced clinical research professional who enjoys operating at the interface of clinical science, regulatory strategy, and customer delivery, and who is motivated by generating robust clinical evidence that enables safe and effective diagnostics to reach patients.
The Role
As Clinical Performance Lead, you will take ownership of multiple clinical performance evaluation studies across diverse therapeutic areas, providing leadership from study design through to final reporting and regulatory submission. You will build strong partnerships with clinical sites, investigators, CROs, and customers, while ensuring studies are delivered to the highest standards of GCP, quality, and compliance. Reporting into senior Quality & Regulatory leadership, you will play a visible role in shaping clinical strategy and supporting both new product development and customer-led programmes.
Key Responsibilities
- Lead the design, management, and delivery of IVD clinical performance evaluation studies
- Provide strategic and operational oversight of multi-site, multi-study clinical programmes
- Ensure full compliance with GCP, IVDR, FDA, and international regulations
- Manage clinical sites, principal investigators, and CROs, including contracts and budgets
- Oversee patient recruitment strategies, timelines, and study risks
- Author and review clinical protocols, reports, summaries, and regulatory documentation
- Coordinate ethics committee and regulatory authority submissions and approvals
- Collaborate closely with R&D, Analytical Development, Regulatory, Quality, and Medical teams
- Support customer interactions, proposals, and scientific/regulatory discussions
- Drive continuous improvement in clinical operations, quality systems, and processes
- Oversee clinical data integrity, data management, and interpretation of results
Required Experience & Qualifications
- Essential Degree in Life Sciences, Medicine, Nursing, or equivalent clinical background
- Experience in clinical research within IVD or medical devices
- Strong working knowledge of GCP and clinical regulatory requirements
- Proven experience designing and managing clinical studies end-to-end
- Solid understanding of IVDR 2017/746, FDA, and international clinical study expectations
- Experience managing clinical sites, investigators, and external partners
- Demonstrated project management capability across complex clinical programmes
Desirable
- Advanced degree (MSc, PhD, MD)
- Background in a GCP-compliant CRO, diagnostics, or pharma environment
- Experience with point-of-care and/or molecular diagnostics
- Exposure to statistical analysis and clinical data interpretation
- Line management, mentoring, or leadership experience
- Clinical research certification (ACRP, SoCRA, or equivalent)
- Experience with EDC systems and medical device QMS
Key Attributes
- Highly organised, analytical, and detail-oriented
- Confident communicator with the ability to influence cross-functional stakeholders
- Comfortable operating in a fast-paced, highly regulated environment
- Solutions-focused, adaptable, and customer-oriented
- Willing to travel occasionally for site visits, audits, and meetings
Why Apply
This is an opportunity to take a high-impact clinical leadership role within a progressive diagnostics organisation committed to innovation, quality, and patient benefit. You will have genuine influence over clinical strategy, regulatory success, and customer outcomes in a growing and highly regulated sector.
Clinical Performance Evaluation Lead employer: CY Partners
Contact Detail:
CY Partners Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Performance Evaluation Lead
✨Tip Number 1
Network like a pro! Reach out to professionals in the IVD and medical device sectors on LinkedIn. Join relevant groups, participate in discussions, and don’t hesitate to ask for informational interviews. Building connections can open doors to opportunities that aren’t even advertised!
✨Tip Number 2
Prepare for interviews by diving deep into the company’s products and recent developments. Show us you’re not just familiar with the basics but also understand their impact on clinical performance evaluation. Tailor your responses to highlight how your experience aligns with their needs.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or mentors to refine your answers and boost your confidence. Focus on articulating your experience in managing clinical studies and compliance with GCP and IVDR regulations.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search. Make sure to follow up after applying to express your enthusiasm!
We think you need these skills to ace Clinical Performance Evaluation Lead
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the specific skills and experiences that match the Clinical Performance Evaluation Lead role. Highlight your clinical research experience, especially in IVD or medical devices, and don’t forget to mention any relevant regulatory knowledge!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about clinical performance evaluation and how your background makes you the perfect fit for our team. Be sure to connect your experiences with the key responsibilities outlined in the job description.
Showcase Your Leadership Skills: Since this role involves leading clinical studies, make sure to highlight any previous leadership or project management experiences. We want to see how you've successfully managed teams or projects in the past, especially in a clinical setting.
Apply Through Our Website: We encourage you to apply directly through our website for the best chance of getting noticed. It’s the easiest way for us to keep track of your application and ensure it reaches the right people. Plus, we love seeing candidates who take that extra step!
How to prepare for a job interview at CY Partners
✨Know Your Regulations
Make sure you brush up on IVDR (2017/746) and FDA regulations before the interview. Being able to discuss how these regulations impact clinical performance evaluation studies will show that you’re not just familiar with the requirements, but that you can navigate them effectively.
✨Showcase Your Leadership Skills
Prepare examples of how you've led clinical studies in the past. Highlight your experience managing multi-site projects and working with CROs. This role is all about leadership, so demonstrating your ability to guide teams and ensure compliance will set you apart.
✨Be Ready for Technical Questions
Expect questions about study design, patient recruitment strategies, and data management. Brush up on your technical knowledge and be prepared to discuss specific challenges you've faced and how you overcame them. This will show your problem-solving skills and depth of experience.
✨Communicate Clearly and Confidently
As a Clinical Performance Evaluation Lead, you'll need to influence various stakeholders. Practice articulating your thoughts clearly and confidently. Use examples from your past experiences to illustrate your points, and don’t shy away from discussing how you’ve collaborated with cross-functional teams.
