Central Risk Manager, RBQM & Central Monitoring

This is a fully remote position, open to applicants in United States, +2 more states.

📋 Description

• Act as a recognized expert in Risk-Based Quality Management (RBQM) and Centralized Monitoring across global clinical initiatives.

• Influence the quality strategy of studies from the review of protocols through to execution.

• Collaborate with sponsors and senior stakeholders to create and implement monitoring strategies.

• Design risk-based monitoring strategies that impact study quality, efficiency, resource use, and patient safety.

• Analyze study protocols to pinpoint critical data, processes, risks, and quality factors.

• Lead and facilitate risk assessments related to protocol execution across various cross-functional teams.

• Develop and enhance RBM and RBQM strategies.

• Prepare and support Risk Assessment and Contingency Plans (RACTs) along with related risk management documentation.

• Identify risk mitigation strategies and ensure proper oversight during study execution.

• Utilize centralized monitoring technologies and analytics platforms for risk detection and oversight.

• Leverage data-driven insights to inform monitoring strategy decisions.

• Suggest modifications to monitoring activities, resource distribution, and oversight strategies.

• Assess outputs from centralized statistical monitoring and advise on necessary actions.

• Present monitoring strategies, risk assessments, and recommendations to stakeholders and sponsors.

• Convey complex risk concepts clearly and influence strategic choices.

• Work in collaboration with Clinical Operations, Data Management, Medical Monitoring, Safety, Quality, and other functional teams.

• Provide guidance and mentorship on RBQM methodologies and monitoring strategies.

• Raise concerns regarding quality, timelines, budgets, or deliverables.

• Assist in business development, proposal creation, and budgeting inputs.

• Contribute to continuous improvement efforts across programs and teams.

⛳️ Requirements

• Bachelor’s degree, RN, or an equivalent combination of education, training, and clinical research experience.

• Extensive experience in clinical research within CROs, biotechnology, or pharmaceutical sectors.

• Profound knowledge of Risk-Based Quality Management (RBQM) methodologies.

• Strong background in Risk-Based Monitoring (RBM) strategies and their implementation.

• Experience or familiarity with Central Monitoring, including methodologies, technologies, and operational execution.

• Experience in conducting study-level risk assessments and formulating monitoring strategies.

• Strong knowledge of ICH-GCP and relevant regulatory standards.

• Excellent verbal and written communication skills with a high level of English proficiency.

• Ability to present complex ideas in a clear and compelling manner.

• Strong capabilities in stakeholder management, negotiation, and influence.

• Exceptional critical thinking, analytical, and problem-solving skills.

• Capacity to work independently in fast-paced and dynamic environments.

• Familiarity with CluePoints, Spotfire, Tableau, Power BI, or similar centralized monitoring and analytics technologies.

• Knowledge of data visualization, trend analysis, outlier detection, data integrity assessment, statistical monitoring, and risk signal detection.

• Advanced skills in Microsoft Excel, including pivot tables, filtering, sorting, and data analysis.

• Understanding of quality risk management principles.

• Familiarity with RACT tools and risk assessment frameworks.

• Interest in emerging technologies, AI, and innovation within the field of clinical research.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management.

• Training in technical and therapeutic areas.

• Peer recognition and a comprehensive rewards program.

• An inclusive workplace culture.

• Company car or car allowance.

• Medical, dental, and vision health benefits.

• 401(k) with company matching.

• Eligibility to participate in the Employee Stock Purchase Plan.

• Opportunity to earn commissions/bonuses based on both company and individual performance.

• Flexible paid time off (PTO).

• Sick leave.

• Access to extensive resources including emerging technologies, data, and knowledge sharing.