Play a key role in advancing clinical research quality by supporting risk management and central monitoring activities across global clinical trials. In this role, you'll help study teams identify, assess and mitigate risks, ensuring trials are conducted in line with ICH GCP guidelines while maintaining a strong focus on quality and patient outcomes. Working cross-functionally with project teams, you'll contribute to the development and execution of Risk-Based Quality Management (RBQM) strategies, support central monitoring activities, and provide valuable insights from data trends, risk indicators and study performance metrics. Your expertise will help drive consistency across studies, programmes and sponsors while supporting inspection readiness and successful study delivery. This is a remote role open to candidates based in UK and Europe. You will collaborate with global teams across multiple time zones.
Responsibilities
Lead and oversee RBQM activities for assigned clinical trials, ensuring alignment with study objectives and regulatory expectations; Develop and maintain Central Monitoring Plans, securing required approvals and supporting effective study oversight; Coordinate cross-functional risk assessments and facilitate the identification of key study risks, KRIs and QTLs where applicable; Support study teams through training and guidance on RBQM strategies, central monitoring approaches and risk management processes; Perform central monitoring reviews, analysing trends, outliers and risk signals to identify potential issues and recommend actions; Contribute to the development and maintenance of study-level monitoring strategies that support quality-focused trial execution; Ensure inspection readiness by maintaining high-quality risk management and central monitoring documentation; Support technology-related activities, including user acceptance testing of RBQM tools and central monitoring solutions; Participate in sponsor meetings, bid defence activities, audits and other stakeholder engagements as required
Requirements
BSc, Registered Nurse qualification, or an equivalent combination of education, skills and experience; At least 4 years of clinical research experience, including a minimum of 3 years of experience in Risk-Based Monitoring and relevant ICH/regulatory guidance; Previous experience working as a Central Monitor or within a central monitoring function; Strong understanding of RBQM principles, risk assessment methodologies, KRIs, QTLs and study monitoring strategies; Ability to analyse complex data, identify trends and outliers, and translate findings into meaningful risk insights and recommendations; Demonstrated critical thinking and problem-solving skills, with the ability to assess issues and determine appropriate solutions; Proven ability to work effectively across functions and within global, cross-cultural teams to achieve project milestones; Proficiency in English, along with strong communication, presentation, organisational and Microsoft Office skills
Wielka Brytania · England
