Central Risk Manager, RBQM & Central Monitoring

🔥 2 hours ago

🌐 United States, Canada – Remote

🇺🇸 United States – Remote 🇨🇦 Canada – Remote

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $95k - $175.7k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🎲 Risk

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Serve as a recognized RBQM and Centralized Monitoring subject matter expert across global clinical programs • Influence study quality strategy from protocol review through study execution • Partner with sponsors and senior stakeholders to develop and execute monitoring approaches • Shape risk-based monitoring strategies affecting study quality, efficiency, resource utilization, and patient safety • 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 RACTs and associated risk management documentation • Identify risk mitigation plans and ensure appropriate oversight throughout study execution • Utilize centralized monitoring technologies and analytics platforms for risk identification and oversight • Use data-driven insights to guide monitoring strategy decisions • Recommend adjustments to monitoring activities, resource allocation, and oversight plans • Evaluate centralized statistical monitoring outputs and recommend actions • Present monitoring strategies, risk assessments, and recommendations to stakeholders and sponsors • Communicate complex risk concepts and influence strategic decisions • Collaborate with Clinical Operations, Data Management, Medical Monitoring, Safety, Quality, and other functional teams • Provide guidance and mentorship on RBQM methodologies and monitoring strategies • Escalate quality, timeline, budget, or delivery concerns • Support business development, proposal development, and budget input • Help drive continuous improvement across programs and teams

🎯 Requirements

• 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 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 • 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 • 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 in fast-paced, evolving environments • Familiarity with CluePoints, Spotfire, Tableau, Power BI, or other centralized monitoring and analytics technologies • Knowledge of data visualization, trend analysis, outlier detection, data integrity assessment, statistical monitoring, and risk signal detection • Advanced Microsoft Excel skills, 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 clinical research

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Inclusive culture • Company car or car allowance • Medical, dental, and vision health benefits • Company match 401(k) • Eligibility to participate in Employee Stock Purchase Plan • Eligibility to earn commissions/bonus based on company and individual performance • Flexible paid time off (PTO) • Sick time • Comprehensive resources including emerging technologies, data, science and knowledge sharing