Lead Business Operations Specialist (RBQM)

Location: Sofia, Lisbon, Madrid, or Reading; remote or office-based work

Company

hirify.global is a global healthcare intelligence and clinical research organisation focused on bringing new medicines and treatments to patients faster.

What you will do

• Lead quality and risk management planning across clinical studies and programs.
• Facilitate cross-functional workshops to identify critical-to-quality factors, critical data, and critical processes.
• Coordinate initial and ongoing risk assessments, risk controls, mitigation plans, and risk surveillance.
• Partner with Clinical Operations, Data Management, Biostatistics, and other stakeholders on data flows, critical data pathways, and monitoring requirements.
• Lead Risk Review Meetings and provide trend analysis, recommendations, and documented decisions.
• Support program-level RBQM governance and continuous improvement initiatives.

Requirements

• Comprehensive clinical research experience in a global, matrixed organisational environment.
• Significant experience in RBQM, Clinical Operations, Central Monitoring, Clinical Risk Management, or Clinical Data Science.
• Strong knowledge of ICH E6 (R2/R3), ICH E8, clinical trial processes, data flows, and risk-based monitoring strategies.
• Demonstrated experience implementing RBQM methodologies across multiple projects.
• Ability to lead cross-functional initiatives, influence global stakeholders, and translate regulatory expectations into operational practice.
• Strong communication, facilitation, critical thinking, and risk anticipation skills.

Culture & Benefits

• Inclusive, collaborative, and values-driven working environment.
• Annual leave entitlements that vary by country.
• Country-specific health insurance, retirement planning, and life assurance options.
• Access to a global employee assistance programme with 24-hour support.
• Flexible optional benefits such as childcare vouchers, gym memberships, travel passes, bike purchase schemes, and health assessments.