Clinical Trial Manager

Overview

The Clinical Trial Manager / Site Delivery Lead will function under the guidance of the Head of Clinical Operations, offering prompt updates on study status, site progress, risks, and any operational challenges across the EMS Community Research Sites. This role is responsible for converting strategic plans into actionable operational tasks, driving high-standard, compliant study execution, and maintaining consistent EMS standards.

Role Responsibilities

• Provide comprehensive operational leadership from study initiation to close-out at EMS Community Research Sites.
• Serve as the site delivery lead, overseeing daily site performance and managing site staff.
• Translate protocols and sponsor requirements into standardized workflows for site teams.
• Ensure site readiness, activation, execution, and closure adhere strictly to protocol, ICH-GCP, and regulatory guidelines.
• Act as the main contact point for clients, CROs, or sponsors and manage escalation procedures.
• Support site teams in preparation for sponsor/CRO monitoring visits, audits, and manage follow-ups on findings.
• Track and analyze operational KPIs such as recruitment, timelines, protocol compliance, and data entry accuracy.
• Drive corrective and preventive actions promptly when necessary.
• Line-manage Site Managers including permanent, contract, and agency staff, setting objectives, providing feedback, and facilitating performance evaluations and coaching.
• Develop staffing frameworks and rotas to optimize study delivery across EMS sites.
• Participate in recruitment, induction, and onboarding processes for site staff.
• Foster a high-performance culture within study teams.
• Manage resource allocation and workload distribution to meet study timelines effectively.
• Ensure all staff complete required GCP and study-specific training and maintain compliance.
• Promote uniform EMS operational standards and best practices through SOP adherence.
• Maintain essential documentation, including investigator site files, to inspection-ready standards.
• Lead issue resolution, risk mitigation, and interdepartmental problem-solving engagements.
• Collaborate closely with Project Management, Operations, Medical, and Regulatory/Quality teams to meet delivery milestones.
• Align EMS operational activities with sponsor expectations.
• Contribute to the refinement of systems, SOPs, and training by capturing lessons learned and recommending improvements.
• Support EMS Community Research Sites in becoming a scalable, high-performing clinical research network.

Required Experience and Qualifications

• At least 5 to 7 years' experience in clinical research, including significant site-level roles such as Clinical Research Coordinator or Senior Site Manager.
• 2 to 3 years' experience managing clinical research personnel with responsibilities for performance and development.
• Demonstrated leadership in multi-study or multi-site clinical research within site networks or similar organizations.
• Solid knowledge of ICH-GCP guidelines and regulatory requirements like MHRA and FDA/EMA at the site level.
• Proven history of meeting or outperforming enrolment, quality, and schedule objectives.
• Familiarity with clinical systems including Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), and other relevant eClinical platforms.

Desirable Experience

• Experience with mobile, community-based, decentralized, or hybrid clinical trial setups.
• Exposure to complex clinical trial protocols requiring strict operational discipline.
• Professional certification in clinical research (e.g., ACRP, SOCRA) or advanced clinical research/operations training.

Key Skills

• Excellent leadership and team management capabilities with clear expectation-setting and accountability enforcement.
• In-depth understanding of daily clinical research site operations including visit flow and documentation.
• Strong organizational capabilities and time management to juggle multiple sites and priorities efficiently.
• Effective problem-solving aptitude coupled with pragmatic and hands-on decision-making.
• Confident communication skills in both written and verbal forms, engaging with multiple stakeholders.
• Analytical mindset for interpreting operational metrics to enhance performance.
• High professional integrity, with commitment to patient safety and ethical research standards.

Additional Requirements

• Resident of the UK with a valid driving license and access to suitable personal transportation.
• Willingness to travel across the UK and internationally if required.

Benefits

• Annual leave starting at 25 days plus bank holidays, increasing to 28 days after five years.
• Opportunity to buy and sell holidays.
• Enhanced maternity and paternity leave schemes.
• One special occasion day annually for personal or family milestones.
• Access to health benefits via Healthshield.
• Participation in Cycle to Work, Tech, and Electric Car schemes.
• Company-subsidized social events and gatherings.
• Support for mental well-being through qualified Mental Health First Aiders and health programs.

Application Details

Applications close on 7th August 2026, with interviews scheduled for 12th August 2026.