Clinical Trial Manager

Role Overview

The Clinical Trial Manager / Site Delivery Lead will report directly to the Head of Clinical Operations and be responsible for delivering frequent, clear updates on study progress, site performance, risks, and operational challenges across EMS Community Research Sites. The role supports the Head in translating strategic goals into operational execution, ensuring consistent application of EMS standards and promoting compliant, high-quality clinical study conduct.

This position involves providing comprehensive operational leadership for clinical research studies at EMS sites, overseeing day-to-day site activities, staff leadership, and ensuring adherence to protocol, ICH-GCP guidelines, and regulatory requirements.

Primary Responsibilities

• Lead operational delivery of clinical research across EMS Community Research Sites.
• Convert protocol and sponsor requirements into standardized procedures for site teams.
• Manage site readiness, activation, study conduct, and close-out phases.
• Ensure protocol compliance, high-quality documentation, and GCP adherence at all stages, acting as the primary accountability holder for site-level quality.
• Serve as the liaison for clients, CROs, and sponsors and manage escalation pathways.
• Support site teams in preparing and responding to monitoring visits and audits, ensuring timely resolution of findings or corrective actions.
• Monitor KPIs such as recruitment targets, participant visit timelines, protocol compliance, and data entry schedules; drive corrective actions as needed.
• Line-manage Site Managers to maintain consistent operational standards across locations.
• Set performance objectives, provide feedback, conduct reviews, and coach staff.
• Assist in staffing structures, schedules, recruitment, onboarding, and induction processes.
• Promote a high-performance culture within study teams.
• Coordinate resource allocation and capacity planning to meet study timelines.
• Ensure all site personnel complete required GCP and study-specific training, maintaining compliance throughout the study.
• Drive adoption of EMS operating procedures and best practices across hubs.
• Maintain essential site documentation to inspection-ready standards.
• Lead resolution of issues, risk management, and cross-functional problem-solving.
• Collaborate with Project Management, Medical, Regulatory, and Quality teams to meet milestones and align expectations.
• Contribute to continuous improvement initiatives, including SOP updates, system enhancements, and training improvements.
• Enable EMS community research sites to function as a scalable, high-performing clinical research network.

Experience and Qualifications

• Minimum 5 to 7 years’ clinical research experience with significant involvement in site-based roles such as Clinical Research Coordinator or Regional Manager.
• At least 2 to 3 years managing clinical research staff including Site Managers and Research Nurses, responsible for their performance and growth.
• Experience leading clinical operations for multi-study or multi-site research within site networks or dedicated research organizations.
• Comprehensive understanding of ICH-GCP, MHRA, FDA/EMA regulations applicable at the site level.
• Proven success in achieving or exceeding enrollment, quality, and timeline goals.
• Familiarity with clinical software platforms such as Electronic Data Capture systems, Clinical Trial Management Systems, and other eClinical technologies.
• Preferably experienced in mobile, community-based, decentralized, or hybrid clinical trial models.
• Knowledge of managing complex protocols requiring strict operational discipline is advantageous.
• Professional certifications like ACRP or SOCRA, or postgraduate training in clinical research/operations, are beneficial.

Key Competencies

• Strong leadership and personnel management abilities, capable of setting clear expectations and accountability.
• Detailed insight into day-to-day operations of high-performing clinical research sites.
• Excellent organization and multitasking skills managing multiple sites and priorities.
• Pragmatic problem-solver with decisive decision-making skills.
• Effective communicator, both written and verbal, able to engage investigators, staff, internal teams, and external partners.
• Data-oriented approach to reviewing operational metrics and improving performance.
• High integrity with dedication to patient safety and ethical standards in research.

Additional Requirements

• Must be a full UK resident with a valid UK driving license and have reliable transport (public transport is not advisable due to location).
• Willingness and ability to travel domestically across the UK and internationally as needed.

Benefits

• Annual leave of 25 days plus bank holidays, increasing to 28 days after 5 years of service.
• Option to buy or sell holiday entitlement.
• Enhanced maternity and paternity leave provisions.
• One personal day off annually for a special occasion of the employee’s choosing.
• Healthshield insurance coverage.
• Cycle to Work scheme participation.
• Access to technology and electric vehicle incentive schemes.
• Company events and social gatherings with subsidized costs.
• Wellbeing support through qualified Mental Health First Aiders and health programs.