Clinical Research Site Manager in North East

Position Summary: Lead the day-to-day operations of a dedicated, flagship clinical research site in Sunderland, ensuring high-quality study conduct, optimal participant experience, operational efficiency, and proactive local community engagement. Working within a DYAD management framework (Site Manager + Principal Investigator/Medical Affairs), you will be accountable for operational delivery, facilities management, health & safety, quality oversight (including CAPA), and local referral network development. The Site Manager is the face of the site—representing it in cross‑functional communications, driving team performance, and continuously identifying ways to improve processes and outcomes.

Key Responsibilities:

• People Management & Site Leadership: Own daily site management including supplies, consumables, and vendor coordination; maintain stock levels and reordering cycles. Diary optimisation: build and manage site calendars for participant visits, staff rosters, room utilisation, and investigator availability to maximise throughput and minimise wait times. Staff management: lead and coach site coordinators, nurses/technicians, Sub‑Investigators, reception/admin; manage onboarding, training compliance, rota creation, holidays/absences, and performance. Ensure adherence to SOPs, protocol requirements, and Good Clinical Practice (GCP). Foster a culture of accountability, collaboration, and continuous improvement.
• Facilities Management (with Landlord): Act as the primary liaison with the landlord and service providers for security, access control, fire safety systems, building maintenance, and cleaning. Oversee statutory and planned preventive maintenance, including fire safety (alarms, extinguishers, emergency lighting, fire drills, evacuation plans), water hygiene (legionella risk assessments, temperature monitoring, flushing logs, annual testing), HVAC/air conditioning servicing and filter changes, electrical safety (PAT testing, fixed wire inspections), clinical waste management, sharps disposal, and contractor performance against service‑level agreements. Maintain facilities documentation (certificates, logs, risk assessments) and ensure audit readiness.
• Participant Logistics & Experience: Oversee participant scheduling, visit flow, and on‑site experience to ensure smooth, timely, and high‑quality visits. Champion a participant‑first experience: reduce wait times, provide clear visit instructions, ensure privacy, dignity, and accessibility. Troubleshoot logistical challenges and implement solutions to improve participant satisfaction and retention. Manage logistics for travel, reimbursements, appointment reminders, and follow‑up communications. Gather participant feedback; track and improve satisfaction metrics.
• Health and Safety: Serve as site Health & Safety lead: maintain risk assessments, COSHH, incident reporting, near‑miss tracking, and mitigation plans. Coordinate First Aid and Fire Marshal coverage; ensure H&S training completion and drills. Ensure accessibility, safeguarding practices, and safe patient flow within the site. Maintain visitor and contractor sign‑in protocols and briefings.
• Study Conduct & Quality Oversight: Prepare the site for study start‑up (SIV readiness, training, room configuration, equipment calibration, IP storage conditions). Oversee participant scheduling, screening, consent (including eConsent), and visit execution; ensure protocol compliance and data integrity. Ensure accurate, timely eSource documentation and query resolution; support approval. Coordinate with PI/Medical Affairs on medical oversight, deviations, and safety reporting (AEs/SAEs) per protocol and regulatory requirements. Support Sponsor/CRO RBQM activities by providing required site‑level data and implementing protocol‑directed mitigations.
• Quality Management & CAPA: Own site‑level quality system adherence: deviation handling, root cause analysis, CAPA planning and closure, and continuous improvement. Ensure electronic regulatory files (eReg) are up to date and compliant via coordinator management and regulatory team collaboration. Ensure document version control and training compliance. Drive readiness for audits/inspections and ensure timely response to findings.
• Community Engagement & Referral Networks: Build and maintain community‑based relationships with local GP practices, pharmacies, community leaders, charities, patient advocacy groups, and regional stakeholders. In collaboration with centralized recruitment teams, develop ethical, compliant referral pathways and outreach initiatives that strengthen the site’s presence and benefit the local community. Collaborate with Marketing/Patient Recruitment teams (e.g., HubSpot) to run campaigns, nurture contacts, and measure conversion across referral channels.
• Technology & Systems Proficiency: Ensure functionality and maintenance of all IT equipment (computers, tablets, printers, etc.). Oversee and train staff on the use of clinical systems including AI‑enabled tools, electronic consent platforms, electronic source and regulatory filing systems, and CTMS platforms (e.g., CRIO, Hubspot). Serve as the liaison with IT support for troubleshooting and upgrades.
• Operational Excellence & Site Representation: Act as the primary point of contact for the site, representing it in internal and external communications. Monitor and report on site productivity, efficiency, and performance metrics. Identify and implement process improvements to enhance operational efficiency and participant experience. Lead site efforts personally and with the team in procuring local services, including vendors where required.

Qualifications:

• Bachelor’s degree in a health‑related field or equivalent experience.
• Demonstrated knowledge of GCP, UK data protection (UK GDPR), and site SOPs; strong audit/monitoring readiness.
• Experience with facilities coordination and Health & Safety in clinical environments.
• Strong stakeholder management: sponsors/CROs, landlords, vendors, community partners.
• Excellent organisational skills, scheduling/diary management, and problem‑solving under time pressure.
• 4–7 years’ experience in clinical research site operations or similar healthcare operations role; experience coordinating/leading teams.
• Strong leadership, organisational, and communication skills with a proven ability to lead teams, manage logistics, and drive operational excellence.
• Proficiency in clinical trial software and Microsoft Office Suite.
• Demonstrated ability to manage participant logistics and lead site operations.
• Ability to travel regionally as needed.

Preferred Skills:

• Experience with CRIO, Hubspot, or similar CTMS platforms.
• Familiarity with AI tools, eSource, eConsent, and electronic regulatory systems.

What We Offer:

• Competitive compensation
• Medical, dental, and vision insurance
• Generous PTO and paid holidays
• Flexible scheduling options
• Professional development and continuing education support
• A mission‑driven team that values respect, inclusion, and innovation

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!