Senior Central Risk Manager, RBQM

🕒 Setembro 10

🏄 California – Remoto

🏄 California – Remote

⏰ Tempo Integral

🟠 Sênior

🎲 Riscos

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Syneos Health

SiteLinkedInTodas as Vagas

10.000+ funcionários

🏥 Saúde

💼 Consultoria

📦 Logística

Healthcare • Consulting • Logistics

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

• Provide expert guidance, training, and support on RBQM in clinical trials • Advise study teams throughout risk management activities and promote cross-functional collaboration • Contribute to central monitoring tools, Quality Tolerance Limits, risks, thresholds, mitigations, and performance indicators • Participate in determining monitoring strategies and mitigation plans, including authoring the Central Monitoring Plan • Facilitate cross-functional risk review meetings and interpret and triage risk signals • Oversee resolution, escalation, and documentation of risk signals and issues • Support development and implementation of central monitoring data analytical tools • Set up and test study-level central monitoring analytics • Map, manage, and design RBQM dataflows across clinical and operational databases • Review central monitoring analytics, investigate signals and actions, and follow up on resolutions • Identify anomalies and monitor trends indicating systematic errors and potential study, site, country, or study issues • Support inspection-readiness and participate in audits and regulatory inspections as an RBQM point of contact • Serve 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 programs and therapeutic areas • Lead or contribute to cross-functional committees, projects, and continuous-improvement workstreams • Develop and analyze RBQM performance metrics • Champion change initiatives, innovation, best practices, and modern ways of working • Build and maintain partnerships with service providers • Represent the Sponsor in industry-wide collaborations and share best practices

🎯 Requisitos

• 8-10 years in clinical research • 3 years of RBQM or Central monitoring experience • Expertise in RBQM strategies, processes, tools, and implementation • Expertise in data analytic software, Analytical Data Visualization Tools, and MS Excel • Proficient in R programming language • Technical understanding of statistical analysis techniques in central monitoring • Advanced analytical and problem-solving skills • Ability to lead without authority and influence stakeholders across functions, cultures, and geographies • Negotiation and conflict resolution skills • Strong verbal, written, and presentation communication skills • Fluent in English, both written and spoken • Strong cross-cultural competency and global collaboration experience • Thorough knowledge of national and global regulations and guidelines governing clinical research • Deep understanding of Phase I-IV clinical studies, clinical operations, and cross-functional study team roles • Advanced expertise in RBQM, including risk-based monitoring, central monitoring methodologies, quality-by-design principles, risk and issue management, and root cause analyses • Outstanding knowledge of RBQM-related IT systems and data flows across clinical and operational applications and databases • High aptitude for data analytics and deep understanding of statistical concepts • Ability to travel as needed • Equivalent experience, skills, and/or education will also be considered

🏖️ Benefícios

• 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 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) • Sick time