Central Risk Manager – RBQM, Central Monitoring

🕒 Junho 3

🌵 Arizona, Maine, +3 estados a mais – Remoto

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

💵 $121.000 - $150.000 / ano

⏰ Tempo Integral

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Syneos Health

SiteLinkedInTodas as Vagas

10.000+ funcionários

🧬 Biotecnologia

💊 Farmacêutico

⚕️ Seguro de Saúde

Biotechnology • Pharmaceuticals • Healthcare Insurance

Syneos Health é uma organização líder, totalmente integrada, de soluções biofarmacêuticas, criada para acelerar o sucesso dos clientes. A empresa transforma insights exclusivos clínicos, de Assuntos Médicos (Medical Affairs) e comerciais em resultados para responder às realidades modernas do mercado. Ao utilizar tecnologias avançadas e insights, a Syneos Health colabora com os clientes para acelerar a entrega de terapias importantes a pacientes no mundo todo, oferecendo serviços que abrangem todo o espectro do clínico ao comercial.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• 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