Central Risk Manager (RBQM & Central Monitoring) - Remote: United States or Canada

Syneos Health, Inc.

Job Overview

Location

52 Locations

Job Type

Full-time

Full Job Description

📋 Description

• Serve as a subject matter expert in Risk-Based Quality Management (RBQM), Risk-Based Monitoring (RBM), and Central Monitoring across global clinical trials.
• Review clinical study protocols to identify critical data points, processes, and quality risks that impact patient safety and trial integrity.
• Lead and facilitate protocol execution risk assessments with cross-functional teams including Clinical Operations, Data Management, Medical Monitoring, Safety, and Quality.
• Develop, refine, and implement Risk-Based Monitoring (RBM) and RBQM strategies tailored to study complexity, therapeutic area, and sponsor requirements.
• Draft and support Risk Assessment Categorization Tools (RACTs) and associated risk management documentation to guide monitoring activities.
• Utilize centralized monitoring technologies and analytics platforms (e.g., CluePoints, Spotfire, Tableau, Power BI) to identify risk signals, trends, and outliers in clinical data.
• Analyze statistical monitoring outputs and recommend data-driven adjustments to monitoring plans, resource allocation, and oversight levels.
• Present risk assessments, monitoring strategies, and recommendations to internal stakeholders and sponsor clients with clarity and confidence.
• Influence study quality strategy from protocol design through execution, ensuring alignment with ICH-GCP and regulatory expectations.
• Build credibility as a trusted advisor by communicating complex risk concepts to diverse audiences, managing competing viewpoints, and driving consensus.
• Collaborate with global clinical research teams to ensure consistency in RBQM methodologies, monitoring approaches, and quality standards across studies and therapeutic areas.
• Mentor colleagues and contribute to continuous improvement of RBQM practices, tools, and training within the organization.
• Support business development efforts by contributing to proposal development, strategy discussions, and budget input for new client engagements.
• Escalate risks proactively when quality, timeline, budget, or delivery concerns threaten study success.
• Stay current with emerging technologies, AI applications, and innovations in clinical risk management and centralized monitoring.
• Operate autonomously in a fast-paced, evolving environment while maintaining high standards of accuracy, compliance, and strategic thinking.
• Foster a collaborative team culture grounded in transparency, accountability, and mutual respect, contributing positively to team dynamics and knowledge sharing.

🎯 Requirements

• Bachelor’s degree, RN, or equivalent combination of education, training, and clinical research experience
• Significant experience in clinical research, CRO, biotechnology, or pharmaceutical environments
• Deep expertise in Risk-Based Quality Management (RBQM) methodologies
• Strong experience with Risk-Based Monitoring (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

🏖️ Benefits

• Eligibility to earn commissions/bonus based on company and individual performance
• Company match 401k
• Health benefits including Medical, Dental, and Vision
• Flexible paid time off (PTO) and sick time
• Eligibility to participate in Employee Stock Purchase Plan
• Company car or car allowance

Skills & Technologies

GCP

Remote

$121k-150k

Degree Required

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Syneos Health, Inc.

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About Syneos Health, Inc.

Syneos Health is a global biopharmaceutical services organization providing clinical and commercial solutions. It integrates clinical development, outsourced commercialization, consulting, and communications services to accelerate the delivery of therapies to market. The company supports pharmaceutical, biotechnology, and medical device clients across all phases of product development and commercialization, operating in North America, Europe, and Asia-Pacific.

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