Location: Sunderland, UK Job Type: Full-Time Reports To: Head of Country Delivery Internal Team Title: Clinical Trial Manager Join Us at Civia Health Civia Health operates a next‑generation SMO model designed for predictable, high‑quality clinical trial delivery. Our approach depends on seamless alignment across specialised functions — Site Management, Recruitment, Regulatory, Data Quality, and Safety — supported by disciplined governance, transparency, and performance accountability. PURPOSE OF THE ROLE The Site Manager leads the operational delivery of a flagship clinical research site within a DYAD model (Site Manager PI/Medical Affairs). They own site P&L, daily operations, staffing, scheduling, facilities management, statutory safety, quality oversight, CAPA execution, study conduct, technology systems, and participant experience. They serve as the operational face of the site, ensuring predictable, high‑quality execution and seamless cross‑functional communication. SUNDERLAND‑SPECIFIC REQUIREMENTS The Site Manager must be local, with strong understanding of Sunderland’s: population health context practical access considerations local healthcare navigation patterns factors influencing trial participation This local awareness ensures operational optimisation and site readiness. THE IMPACT YOU WILL HAVE Deliver predictable, high‑quality operational, financial, and quality performance. Maintain full inspection readiness and robust quality systems. Build a high‑accountability, high‑performance site team. Lead an efficient, participant‑first on‑site experience. Ensure facilities, safety, equipment, and statutory compliance. Manage smooth internal coordination with CEMs, Recruitment, CTMs, and Quality. Provide accurate site‑level reporting and drive operational efficiency. KEY RESPONSIBILITIES 1. SITE LEADERSHIP & PEOPLE MANAGEMENT Lead all daily site operations, supplies, consumables, and vendor coordination. Manage and coach site staff (coordinators, nurses/technicians, Sub‑Is, admin). Oversee onboarding, training currency, rota management, holidays/absences. Run structured stand‑ups, weekly reviews, and risk escalation cycles. Foster a culture of accountability, collaboration, and continuous improvement. 2. PARTICIPANT EXPERIENCE & VISIT FLOW Oversee participant scheduling, flow, wait times, privacy, accessibility, and on‑site logistics. Troubleshoot daily bottlenecks and ensure smooth, high‑quality visit execution. Manage reminders, travel logistics, reimbursements, and follow‑ups. Track satisfaction metrics and implement visit‑flow improvements. 3. FACILITIES MANAGEMENT & STATUTORY COMPLIANCE Serve as the primary liaison with the landlord and building service providers. Oversee statutory and planned maintenance: fire safety, water hygiene, HVAC, electrical safety, waste, access control. Maintain all certificates, logs, and risk assessments. Conduct daily readiness walk‑arounds and weekly facilities audits. 4. HEALTH & SAFETY LEADERSHIP Act as H&S lead: risk assessments, COSHH, incident and near‑miss reporting, mitigation. Coordinate Fire Marshal and First Aid rota, drills, and training. Maintain safeguarding, visitor/contractor protocols, and safe patient flow. 5. STUDY CONDUCT, QUALITY & DYAD COLLABORATION Prepare site for study start‑up (SIV readiness, training, equipment calibration, room setup, IP conditions). Oversee screening, consent (incl. eConsent), visit execution, protocol adherence. Ensure accurate eSource and timely query resolution. Support PI/Medical Affairs with deviations, AEs/SAEs, and safety reporting. Provide site‑level data for RBQM and support monitoring/audits. Ensure eReg/eISF completeness and compliant document control. 6. QUALITY SYSTEMS, RCA & CAPA OWNERSHIP Lead site‑level deviation management, root cause analysis, and CAPA planning/execution. Maintain training compliance, version control, and continuous inspection readiness. Respond rapidly to monitoring and audit findings. 7. REFERRAL & PATHWAY INTEGRATION (Commuity engagement manager) The Site Manager oversees the Community Engagement Manager (CEM) and ensures the site is operationally ready to receive and process referrals from GP practices, community organisations, and central teams through smooth scheduling, communication, and onboarding. They work with the CEM and Recruitment to align capacity and maintain efficient referral workflows, while external outreach, partnership development, and community‑facing activities remain fully owned by the CEM. 8. TECHNOLOGY & SYSTEMS Oversee IT equipment readiness; coordinate with IT support. Ensure staff proficiency in AI‑enabled tools, eConsent, eSource/eReg, CTMS (CRIO, HubSpot). Maintain digital compliance and system reliability. 9. OPERATIONAL EXCELLENCE & SITE REPRESENTATION Act as the site’s operational point of contact for internal/study teams. Track and report site KPIs, throughput, and performance. Lead local vendor procurement for operational needs. Identify and implement continuous improvement opportunities. COMPETENCIES Core Patient‑Centred Leadership Operational Excellence & Delivery Ownership & Accountability Financial & P&L Management Facilities, H&S & Statutory Compliance GCP & Regulatory Understanding Data‑Driven Decision‑Making Team Coaching & Development Rapid Risk Identification & Mitigation Civia‑Specific High Accountability & Early Escalation Insight‑Driven Action Calm, Professional, Composed Patient‑First Mindset Continuous Improvement Orientation PHENOTYPE SUMMARY Treats the site and P&L like their own business Obsessed with participant experience Proactive operator; anticipates and solves early Highly attentive to facilities, safety, and operational detail Compliance‑anchored and inspection‑ready daily Builds high‑morale, high‑performance teams Data‑driven and action‑oriented Deeply connected to Sunderland’s community Holds high standards and consistently exceeds expectations WHY CIVIA HEALTH Join a purpose-driven organization redefining clinical research by connecting science with humanity. As part of our leadership team, you’ll shape how clinical trials are delivered, expand access for patients, and accelerate innovation for the communities we serve. Ready to Make an Impact? Mission with Meaning: Be part of a purpose-led team committed to health equity and real-world impact. Startup Energy, Proven Expertise: Work fast, adapt quickly, and help build something new; guided by seasoned visionary professionals who’ve seen what needs to change. People First Culture: We care deeply about our patients, participants, and each other. Collaboration, transparency, and bold, straight-talking are core to how we work. Invested in Your Growth: We don’t just hire for today; we’re building the leaders and changemakers of tomorrow. If you’re ready to be part of something meaningful—and work with people who care deeply about doing good work—apply today by submitting your resume and cover letter to the link above. We’re excited to learn more about you! Powered by JazzHR