Quality Risk Manager

🕒 Abril 21

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $80.000 - $108.000 / ano

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

🎲 Riscos

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Rho

SiteLinkedInTodas as Vagas

501 - 1000 funcionários

Fundada em 1984

💳 Fintech

🤝 B2B

🏦 Bancário

Fintech • B2B • Banking

A Rho é um tipo diferente de CRO construído em torno da conexão. Somos uma comunidade de mentes curiosas e solucionadores de problemas que acreditam que a pesquisa clínica é sobre forte colaboração com todos os envolvidos: patrocinadores, investigadores, locais e pacientes. Nosso conjunto abrangente de serviços de desenvolvimento clínico e áreas de especialização refletem nossa incansável busca por fazer parte de algo maior. Não apenas navegamos por desafios, prosperamos neles criando laços mais fortes. A Rho oferece uma gama de serviços, incluindo gerenciamento de projetos clínicos, estratégia regulatória e submissões, biometria e garantia de qualidade, com foco em neurologia, psiquiatria, questões respiratórias e imunologia. Nossa equipe experiente garante que os ensaios clínicos sejam eficientes e eficazes, aproveitando insights estratégicos e fortes relacionamentos no setor de saúde.

Descrição

• Manages project-level RBQM activities and documents for multiple projects • Facilitates and leads study-specific risk assessments and suggests appropriate anticipated risks and mitigations • Reviews and understands protocol, critical data and process, safety, and data integrity risks related to protocol execution • Ensures project teams develop an integrated quality risk management strategy in compliance with ICH E6R3 guidelines • Participates in ongoing RBQM process and tool optimization activities • Develops and maintains Integrated Quality Risk Management Plan (IQRMP) and Quality Risk Log for assigned studies in coordination with cross functional team • Documents observations and actionable items noted during reviews; investigates trends, issues, and risks for root cause • Documents completion of activities via tracking, reporting, and/or other required project documents as per SOP • Reviews and understands protocol, critical data and process, safety, and data integrity risks related to protocol execution • Reviews study and site data listings and visualizations to identify trends, risks, potential or suspected scientific misconduct, or other systematic errors that could impact data integrity and subject safety • Immediately communicates and escalates serious issues to the relevant project team member(s) and, with guidance, develops action plans • Initiates set-up and provides inputs needed for Key Risk Indicator (KRI) visualizations, using either a technology platform or an alternate tool • Applies knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes • Keeps up with industry trends, including changes to regulations or standard practices • Ensures adherence to compliance standards across all RBQM activities • For assigned activities, understands project scope, budgets, and timelines; manages study activities to ensure project objectives, deliverables, and timelines are met • Attends sponsor kick-off meetings and may attend Investigator Meetings. • Participates in project staff meetings as applicable • Coordinates and manages cross-functional activities and responsibilities for assigned study teams • Collaborates with study team management to define and enforce compliance with Rho RBQM processes and contracted activities • Attends clinical training sessions according to the project-specific requirements • May support training and mentoring of Associate QRM • Supports internal and sponsor audits and participates in efforts to ensure readiness • Identifies opportunities for process improvements and communicates to RBQM leadership

🎯 Requisitos

• Bachelor Degree in science or a related field • 3 years of industry experience • Applicable experience in one or more of the following in a clinical research setting: clinical monitoring, data management, biostatistics, or related function; and/or at least 1 year of strong performance in an AQRM role • Sound knowledge of Good Clinical Practice/ICH E6 (R3) Guidelines, Risk-Based Monitoring strategies, processes and tools and/or other applicable regulatory requirements and industry trends • Basic knowledge of clinical data collection, monitoring, and review processes • Solid understanding of the entire clinical data lifecycle, from protocol creation through database lock and analysis • Able to quickly adapt to changing priorities to achieve goals/targets • Able to assess and implement protocol-specific Quality Management approaches as needed, while collaborating with the appropriate impacted functions. • Ability to maintain confidentiality • Proactively takes initiative to identify next steps, issues, or gaps, and drive tasks forward with minimal guidance • Ability to set priorities and manage multiple projects within moderate oversight • Ability to work independently, prioritize responsibilities, and work in a team environment • Demonstrates strong computer skills and is able to embrace new technologies • Strong competency with MS Excel functionality (sorting, filtering, calculations, pivot tables) • Proficiency with Analytical Data Visualization Tools • Demonstrates the ability to think critically, problem solve and apply sound judgment and reasoning for assigned tasks • Communicates clearly and professionally in written and verbal formats with both internal and external stakeholders, translating moderate-to-complex concepts into clear, actionable messages • Solid presentation skills, both written and spoken, with an ability to inform, influence, convince, and persuade • Expected required travel 15% on average

🏖️ Benefícios

• Rho provides a comprehensive benefits package for all benefit-eligible employees, which includes medical, vision, dental, HSA, FSA, EAP, life & disability insurance and 401(k). • All employees are eligible for paid time off, holidays, parental leave and bereavement leave. • We encourage a work-life balance that allows employees to bring their best selves to work while being passionate about their lives outside work.