Lead Business Operations Specialist

This is a fully remote position, open to applicants in United Kingdom, +3 more countries.

📋 Description

• Lead the implementation of Quality and Risk Management strategies in accordance with study and program goals.

• Conduct cross-functional workshops to identify and document Critical-to-Quality factors, as well as critical data and processes.

• Coordinate and manage initial and ongoing risk assessments.

• Ensure that risk assessments, risk controls, and mitigation plans are thorough, actionable, and aligned with regulatory standards.

• Collaborate with Clinical Operations, Data Management, Biostatistics, and other stakeholders to evaluate data flows, critical data pathways, and data review requirements.

• Contribute to Risk-Based Monitoring strategies, including targeted SDV/SDR approaches and reduced verification models.

• Conduct quality gate reviews of functional plans.

• Lead and facilitate Risk Review Meetings, documenting risk evaluations and decisions.

• Oversee continuous risk surveillance, ensuring monitoring strategies remain effective and aligned with study timelines and budgets.

• Ensure that risk review outputs deliver valuable insights, trend analyses, and actionable recommendations.

• Update risk assessments based on protocol amendments, new signals, or changes to critical data and processes.

• Support program-level and organizational RBQM governance and oversight activities.

• Contribute to continuous improvement initiatives aimed at enhancing RBQM maturity and effectiveness throughout the organization.

• Lead the implementation and execution of proactive, risk-focused quality oversight across clinical studies.

• Drive the establishment of study-level RBQM strategies, standards, and initiatives to enhance quality oversight and readiness for inspections.

⛳️ Requirements

• Extensive clinical research experience, collaborating with global teams in a matrixed organizational setting.

• Significant background in clinical research related to Risk-Based Quality Management (RBQM), Clinical Operations, Central Monitoring, Clinical Risk Management, or Clinical Data Science.

• Strong understanding of ICH E6 (R2/R3), ICH E8, and their application in RBQM.

• In-depth knowledge of clinical trial processes, data flows, and risk-based monitoring strategies.

• Proven expertise in implementing RBQM methodologies across multiple projects.

• Demonstrated ability to lead cross-functional initiatives and influence stakeholders at a global level.

• Strong strategic thinking skills, with the capability to translate regulatory expectations into operational practices.

• Excellent communication, stakeholder engagement, and facilitation abilities.

• Proactive and solutions-driven with a strong emphasis on quality and continuous improvement.

• Ability to function effectively in complex, global environments.

• Strong critical thinking and risk anticipation skills.

• Passion for mentoring teams and enhancing RBQM capabilities across the organization.

• Commitment to promoting an inclusive and collaborative culture.

• Legal authorization to work in the country where the position is based.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.