Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Lead and manage clinical performance evaluation studies in diagnostics.
- Company: Dynamic company at the forefront of IVD immunoassay development.
- 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 focused on innovation and quality in healthcare.
The predicted salary is between 36000 - 60000 ÂŁ 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
- 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: Cypartners
Contact Detail:
Cypartners 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, attend webinars, and don’t be shy about asking for informational interviews. We all know that sometimes it’s not just what you know, but who you know!
✨Tip Number 2
Prepare for those interviews by researching the company inside out. Understand their products, values, and recent news. We want you to walk in with confidence, ready to discuss how your experience aligns with their goals, especially in clinical performance evaluation.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or mentors. Focus on articulating your experience in managing clinical studies and compliance with GCP and IVDR. We’re here to help you shine when it counts!
✨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 and engaged. Let’s get you that Clinical Performance Evaluation Lead role!
We think you need these skills to ace Clinical Performance Evaluation Lead
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Clinical Performance Evaluation Lead role. Highlight your experience in clinical research, especially within IVD or medical devices, and showcase any relevant qualifications that align with the job description.
Craft a Compelling Cover Letter: Your cover letter should tell us why you're the perfect fit for this role. Share specific examples of your past experiences in managing clinical studies and how they relate to the responsibilities outlined in the job description.
Showcase Your Regulatory Knowledge: Since this role involves compliance with GCP, IVDR, and FDA regulations, make sure to emphasise your understanding of these areas. Mention any relevant certifications or experiences that demonstrate your expertise in regulatory requirements.
Apply Through Our Website: We encourage you to apply directly through our website. This way, we can ensure your application gets the attention it deserves, and you can easily keep track of your application status!
How to prepare for a job interview at Cypartners
✨Know Your Regulations
Familiarise yourself with IVDR (2017/746) and FDA regulations. Be prepared to discuss how your experience aligns with these standards, as this role heavily relies on compliance and regulatory knowledge.
✨Showcase Your Leadership Skills
Prepare examples of how you've led clinical studies from design to reporting. Highlight your ability to manage teams and collaborate with various stakeholders, as this position requires strong leadership in a multi-site environment.
✨Demonstrate Your Analytical Mindset
Be ready to discuss your approach to data integrity and interpretation. Share specific instances where your analytical skills have contributed to successful clinical outcomes, as this will resonate well with the role's focus on robust clinical evidence.
✨Engage with Customer-Centric Examples
Think of examples where you've successfully interacted with customers or external partners. This role values customer delivery, so showcasing your ability to build strong relationships will set you apart in the interview.
