Lindus Health

Director

• Lead on GCP quality across the business: audit programme design and execution, inspection readiness, and ongoing compliance with ICH GCP and applicable regulations (UK, EU, US)
• Provide hands-on GCP auditing of trials, sites, vendors, and internal processes - working with clinical operations teams to identify risks and drive corrective actions
• Prepare staff and trial materials for external sponsor audits and regulatory inspections, supporting the team through the process and any required follow-up
• Assess and advise on potential serious breaches, protocol deviations, and GCP quality issues, ensuring appropriate reporting and resolution
• Keep current with evolving regulations and guidance, translating these into practical updates for the clinical operations and quality teams
• Provide ad-hoc US regulatory and FDA-specific good practice guidance as our US trial portfolio expands
• Maintain overall oversight of the Integrated Management System (IMS), working with the Business Quality Manager to ensure ISO 9001 and ISO 27001 processes are implemented and continuously improved
• Ensure quality documentation - SOPs, policies, risk assessments - is accurate, current, and practical for the teams using it
• Oversee deviation, CAPA, and vendor management processes across the business
• Review clinical operations study documents in development to ensure compliance with current clinical trial regulations
• Collaborate with our external GCP support partners (audit consultancies, regulatory advisors) to supplement in-house capability where needed
• Line manage the Business Quality Manager and GCP Quality Associate, ensuring both streams of quality work are resourced, prioritised, and delivering value
• Build strong working relationships with clinical operations leadership (US and UK), product/engineering, and commercial teams - quality needs to be embedded, not siloed
• Contribute to the wider operations leadership team on quality strategy, risk, and compliance matters

Director of Clinical Quality

Vice President

• Lead on GCP quality across the business: audit programme design and execution, inspection readiness, and ongoing compliance with ICH GCP
• Provide hands-on GCP auditing of trials, sites, vendors, and internal processes - working with clinical operations teams to identify risks and drive corrective actions
• Prepare staff and trial materials for external sponsor audits and regulatory inspections, supporting the team through the process and any required follow-up
• Assess and advise on potential serious breaches, protocol deviations, and GCP quality issues
• Keep current with evolving regulations and guidance
• Provide ad-hoc US regulatory and FDA-specific good practice guidance as our US trial portfolio expands
• Maintain overall oversight of the Integrated Management System (IMS)
• Ensure quality documentation - SOPs, policies, risk assessments - is accurate, current, and practical for the teams using it
• Line manage the Business Quality Manager and GCP Quality Associate, ensuring both streams of quality work are resourced, prioritised, and delivering value

Fractional VP of Quality

Data Scientist

• Become an expert on the electronic data capture (EDC) capabilities of Citrus, our end-to-end trial delivery platform
• Act as the data management lead for multiple trials at a time, from early design to closeout
• Trial setup
• Ensure the highest quality outcome data for a trial from an early design stage by advising sponsors and study teams on all aspects of data management
• Create and contribute to trial design documents such as data management plans
• Design CRFs and questionnaires to collect the highest quality data in the most efficient, accurate and user-friendly way
• Develop processes to test the trial implementation and support clinical operations in providing evidence of robust user acceptance testing (UAT)
• Support ongoing live trials with expertise on data-related concerns, such as data queries, data cleaning and change control for the trial design
• Provide data extracts and reports to clinical operations for ongoing central monitoring of the data
• Develop and support processes during trial closeout, such as data cleaning, preparation and transfer
• Collaborate with the product team to make data management within Citrus easy and efficient
• Help the product team stay on top of the trial pipeline by capturing and prioritising new requirements for upcoming trials
• Advise others across the company on the use of data standards such as CDISC SDTM, ADaM, SAS
• Mentor more junior members of the team

Senior Data Manager

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Data Manager

Clinical Operations

• Lead our UK & EU Clinical Operations team
• Responsible for our portfolio of trials and scaling our UK & EU operations
• Use AI tools to reshape and improve clinical operations, trial oversight and trial delivery
• Input on the roadmap and features of our proprietary trial technology platform, Citrus
• Oversee the UK & EU Clinical Operations team, ensuring that trials are delivered successfully (on time, on budget, in compliance, and of high quality)
• Create and maintain optimal working practices, SOPs, systems and tools for robust Study Management execution and stakeholder communications
• Work with Clinical Operations leadership to proactively solve issues
• Direct Project Support staff and mentor project management and clinical staff; facilitate team building and communication
• Implement resource strategies to achieve project goals
• Develop contingency planning and risk mitigation strategies
• Lead hiring and expansion of the UK & EU ClinOps team
• Develop and deliver team training reflective of current best practice
• Ensure seamless integration of our US Clinical Operations team

Director of Clinical Quality

Fractional VP of Quality

Senior Data Manager

Data Manager

VP of ClinOps