Senior Central Risk Manager, RBQM

This is a fully remote position, open to applicants in California.

📋 Description

• Deliver expert guidance, training, and support on Risk-Based Quality Management (RBQM) in clinical trials.

• Consult with study teams during risk management activities and encourage cross-functional collaboration.

• Contribute to central monitoring tools, Quality Tolerance Limits, risks, thresholds, mitigations, and performance indicators.

• Engage in the formulation of monitoring strategies and mitigation plans, including drafting the Central Monitoring Plan.

• Lead cross-functional risk review meetings and analyze and prioritize risk signals.

• Supervise the resolution, escalation, and documentation of risk signals and issues.

• Assist in the development and implementation of central monitoring data analytical tools.

• Establish and evaluate study-level central monitoring analytics.

• Map, manage, and design RBQM data flows across clinical and operational databases.

• Review central monitoring analytics, investigate signals and actions, and ensure follow-up on resolutions.

• Detect anomalies and monitor trends that may indicate systematic errors and potential study, site, country, or study issues.

• Support inspection readiness and participate in audits and regulatory inspections as the RBQM point of contact.

• Act as Subject Matter Expert and Process Owner for assigned areas, processes, and technologies.

• Develop, enhance, and implement RBQM processes, systems, templates, tools, and training materials.

• Manage RACT libraries across various programs and therapeutic areas.

• Lead or contribute to cross-functional committees, projects, and continuous improvement workstreams.

• Develop and analyze RBQM performance metrics.

• Advocate for change initiatives, innovation, best practices, and modern working methods.

• Cultivate and maintain partnerships with service providers.

• Represent the Sponsor in industry-wide collaborations and disseminate best practices.

⛳️ Requirements

• 8-10 years of experience in clinical research.

• 3 years of experience in RBQM or Central monitoring.

• Proficient in RBQM strategies, processes, tools, and their implementation.

• Expertise in data analytic software, Analytical Data Visualization Tools, and MS Excel.

• Skilled in R programming language.

• Technical proficiency in statistical analysis techniques related to central monitoring.

• Strong analytical and problem-solving abilities.

• Capability to lead without authority and influence stakeholders across various functions, cultures, and geographic locations.

• Negotiation and conflict resolution skills.

• Excellent verbal, written, and presentation communication abilities.

• Fluent in English, both spoken and written.

• Strong cross-cultural competency and experience in global collaboration.

• Comprehensive knowledge of national and international regulations and guidelines governing clinical research.

• In-depth understanding of Phase I-IV clinical studies, clinical operations, and roles within cross-functional study teams.

• Advanced expertise in RBQM, including risk-based monitoring, central monitoring methodologies, quality-by-design principles, risk and issue management, and root cause analyses.

• Exceptional knowledge of RBQM-related IT systems and data flows across clinical and operational applications and databases.

• High aptitude for data analytics and a profound understanding of statistical concepts.

• Willingness to travel as needed.

• Equivalent experience, skills, and/or education will also be considered.

🏝️ Benefits

• Opportunities for career development and progression.

• Supportive and engaged line management.

• Technical and therapeutic area training.

• Peer recognition and total rewards program.

• Company car or car allowance.

• Medical, Dental, and Vision health benefits.

• Company match for 401k.

• Eligibility to participate in the Employee Stock Purchase Plan.

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

• Flexible paid time off (PTO).

• Sick time.