Risk Manager

Job Responsibilities

• Serve as a recognized risk‑based quality management (RBQM) and Central Monitoring subject matter expert across global clinical programs.
• Influence study quality strategy from protocol review through study execution.
• Partner directly with sponsors and senior stakeholders to develop and execute monitoring approaches.
• Shape risk‑based monitoring strategies that impact study quality, efficiency, resource utilization, and patient safety.
• Operate in a highly consultative role with significant visibility and organizational influence.
• Leverage advanced analytics and centralized monitoring methodologies to drive proactive risk identification and mitigation.
• Collaborate with experienced cross‑functional clinical research professionals.
• Work at the forefront of evolving RBQM methodologies, technology platforms, data analytics, and emerging innovations within clinical research.
• Mentor colleagues and help drive continuous improvement across programs and teams.

• Review study protocols to identify critical data, processes, risks, and quality considerations.
• Lead and facilitate protocol execution risk assessments across cross‑functional teams.
• Develop and refine RBM and RBQM strategies.
• Draft and support Risk Assessment Categorization Tools (RACTs) and associated risk management documentation.
• Identify risk mitigation plans and ensure appropriate oversight throughout study execution.

• Utilize centralized monitoring technologies and analytics platforms to support risk identification and oversight.
• Leverage data‑driven insights to guide monitoring strategy decisions.
• Ensure monitoring approaches remain aligned with evolving study risks and operational realities.
• Recommend strategic adjustments to monitoring activities, resource allocation, and oversight plans when necessary.
• Evaluate centralized statistical monitoring outputs and recommend appropriate actions.
• Support adoption of innovative technologies and emerging approaches to risk management.

• Present monitoring strategies, risk assessments, and recommendations to internal stakeholders and sponsors.
• Clearly communicate complex risk concepts to diverse audiences.
• Present recommendations with confidence while managing questions, challenges, and competing viewpoints.
• Build credibility as a trusted advisor capable of influencing strategic decisions.
• Facilitate collaborative discussions focused on quality, compliance, efficiency, and patient safety.

• Collaborate with Clinical Operations, Data Management, Medical Monitoring, Safety, Quality, and other functional teams.
• Provide guidance and mentorship regarding RBQM methodologies and monitoring strategies.
• Ensure consistency across studies, programs, therapeutic areas, and sponsor engagements.
• Escalate risks appropriately and proactively when quality, timeline, budget, or delivery concerns arise.
• Support business development activities including strategy discussions, proposal development, and budget input as needed.

• Bachelor’s degree, RN, or equivalent combination of education, training, and clinical research experience.
• Significant experience within clinical research, CRO, biotechnology, or pharmaceutical environments.
• Deep expertise in RBQM methodologies.
• Strong experience with RBM strategies and implementation.
• Central Monitoring experience or exposure, including methodologies, technologies, and operational execution.
• Demonstrated experience conducting study‑level risk assessments and developing monitoring strategies.
• Strong understanding of ICH‑GCP and applicable regulatory requirements.
• Excellent verbal and written communication skills with strong English proficiency.
• Proven ability to present complex concepts clearly and persuasively.
• Strong stakeholder management, negotiation, and influencing capabilities.
• Exceptional critical thinking, analytical, and problem‑solving skills.
• Ability to work independently within fast‑paced, evolving environments.

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