Clinical Research Analyst

# Clinical Research Analyst

At [Employer hidden — view at passion-project.co.uk], robust clinical and economic evidence is the foundation of our "license to operate" and our commercial success. We are building a cross-functional "Evidence Squad" to drive our evidence generation strategy forward. We are seeking a highly motivated and detail-oriented Clinical Research Analyst to support our dual-track evidence strategy. In this critical role, you will help generate the clinical data required for Medical Device Regulation (MDR) compliance (proving safety and performance) while simultaneously supporting healthcare delivery evaluations for Health Technology Assessments (NICE) to demonstrate clinical and economic value to the NHS and European Health Care Systems.

MDR Evidence Generation (Safety & Performance)

• Clinical Evaluation: Support the drafting and continuous updating of Clinical Evaluation Reports (CERs) required for Class II Software as a Medical Device (SaMD) under UKCA/CE mark requirements.
• Post-Market Clinical Follow-up (PMCF): Assist in analyzing post-market surveillance and safety data to ensure ongoing compliance with MHRA SaMD guidance.
• Literature Reviews: Conduct systematic literature reviews using reproducible methodologies (e.g., PRISMA) to support state-of-the-art (SOTA) analyses and identify relevant clinical data.
• Regulatory Alignment: Collaborate with the Regulatory Affairs/Quality Assurance (RA/QA) team to ensure clinical evidence aligns with ISO 13485 and IEC 62304 standards and fits seamlessly into the product Technical File.

Healthcare Delivery & Economic Evaluations (Value & Impact)

• NICE Evidence Standards Framework (ESF): Assist in gathering, mapping, and analyzing data to meet NICE Tier C evidence requirements (demonstrating both effectiveness and economic impact).
• Data Appraisal & Benchmarking: Map historical research and appraise existing internal data to identify publication opportunities (abstracts, posters, and quality improvement projects).
• Competitor Analysis: Benchmark [Employer hidden]’s clinical evidence base against key competitors in the virtual ward and remote patient monitoring space.

Project Coordination & Data Operations

• Vendor & Partner Support: Act as a liaison with external academic partners, health economic consultancies and publication specialists.
• Data Access Coordination: Support the administrative and scoping processes for accessing NHS Secure Data Environments (SDEs) and regional data requests.
• Evidence Squad Collaboration: Work cross-functionally with data scientists, medical writers, clinical safety officers (CSOs), and external Principal Investigators to execute the Evidence Generation Plan.

Education: Bachelor’s or Master’s degree in Life Sciences, Public Health, Health Economics, Epidemiology, Clinical Research, or a related field.

Experience: 3+ years of experience in clinical research, health economics and outcomes research (HEOR), or regulatory affairs within the medical device, digital health, or pharmaceutical industry.

Regulatory Knowledge: Familiarity with Medical Device Regulations (MDR/UKCA), specifically requirements for Clinical Evaluation Reports (CERs) for Class II devices.

HTA/NHS Knowledge: Understanding of the UK healthcare landscape, the NICE Evidence Standards Framework (ESF) for digital health technologies, and NHS commissioning drivers.

Analytical Skills: Strong ability to synthesize complex clinical data, appraise real-world evidence (RWE), including bias, confounding, and data completeness challenges. Translate findings into compelling narratives for different audiences (regulators vs. healthcare providers). Sound statistical literacy, with the ability to interpret observational data and predefined analytical outputs critically.

Technical: High proficiency in using the Google Workspace ecosystem for seamless cross-functional collaboration and document management.

Statistical Analysis in Google Sheets: Advanced ability to clean data, build complex formulas, and execute rigorous statistical analyses directly within Google Sheets (utilizing native statistical functions, array formulas, or analysis add-ons).

AI-Assisted Research & Literature Reviews: Hands-on, practical experience using modern AI tools to accelerate literature reviews, synthesize clinical findings, and streamline academic writing. Specifically, active experience using tools like Prism (OpenAI) for scientific editing/formatting and Consensus for evidence extraction and academic sourcing is key.

Communication: Excellent written and verbal communication skills, with a track record of supporting the creation of clinical summaries, protocols, or publications.

Experience working directly with Software as a Medical Device (SaMD) or AI-driven healthcare technologies.

Familiarity with navigating NHS Secure Data Environments (SDEs) or Data Protection Impact Assessments (DPIAs) regarding patient consent and data processing.

Previous experience coordinating with external Contract Research Organizations (CROs) or academic evaluation partners.