Central Risk Manager – RBQM, Central Monitoring

🔥 0 minutes ago

🌵 Arizona, Maine, +3 more states – Remote

🌵 Arizona – Remote 🦞 Maine – Remote 🌲 North Carolina – Remote 🏈 Ohio – Remote ⚓ Rhode Island – Remote

💵 $121k - $150k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🎲 Risk

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

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 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 • Opportunity to mentor colleagues and 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 • 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

🏖️ Benefits

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