Single Sponsor Global Clinical Trial Manager II (Solid CRA background) fully home based in UK, Poland, Spain and Bulgaria only.

Overview

As a Global Clinical Trial Manager II, you will oversee site management, monitoring, and central monitoring with emphasis on patient safety and data integrity. You’ll manage interactions from activation to closeout, coordinating with cross-functional teams to meet milestones and budgets. You’ll apply risk-based approaches to mitigate threats to trial delivery and ensure regulatory compliance. This role offers collaboration with a global network and opportunities to shape trial execution in a fast-paced, patient-focused environment.

Pay / Benefits

• career development and progression
• supportive and engaged line management
• technical and therapeutic area training
• peer recognition
• total rewards program
• inclusive culture

Responsibilities

• Oversee site management, monitoring and central monitoring activities across the study lifecycle
• Manage site interactions post-activation through closeout, including patient recruitment and investigator payments
• Identify data/process risks and apply mitigations using RACT and monitoring plans
• Review scope, budget and protocol content to guide the clinical team and ensure compliance
• Escalate risks to project manager related to timeline, quality, budget or scope
• Lead or participate in key meetings (e.g., Kick Off) and coordinate with functional leaders to meet milestones
• Develop and maintain clinical study tools, templates and CTMS/ETMS dashboards; oversee UAT and audit trails
• Coordinate training for the study team on protocol specifics, CRFs, SOPs, data plans and timelines
• Oversee resource allocations and conduct for CRAs and Central Monitors, ensuring quality and timely delivery
• Monitor and review trial systems (CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS) for data updates and execution
• Ensure compliance with monitoring strategy, CMP/SMP and risk plans across the study
• Coordinate client interactions, provide status updates, and propose solutions to obstacles in protocol execution
• Support inspection readiness and contribute to data lock and cut strategies
• Provide feedback on staff performance and participate in larger, more complex trials

Key requirements

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
• Demonstrated ability to lead and align teams to achieve milestones
• Experience in international environments
• Expertise in site management and monitoring (clinical or central)
• Knowledge of Good Clinical Practice/ICH guidelines and regulatory requirements
• Strong computer skills and proficiency with relevant clinical trial systems
• Excellent communication, presentation and interpersonal skills; conflict resolution abilities
• Ability to apply problem-solving techniques and risk management to clinical projects
• Willingness to travel ~20%

• communication
• interpersonal skills
• conflict resolution
• site management and monitoring
• risk-based monitoring
• budget management and financial principles

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