Central Monitor I

hace 2 meses


Ciudad de México CDMX AbbVie A tiempo completo

**Company Description**

Position based in Mexico, 100% remote.

**Purpose**:
Central Monitoring and Risk Management is at the heart of AbbVie’s end-to-end RBQM model—a critical pillar required in AbbVie’s mission to be a world-class R&D organization.

The purpose of the Central Monitor is to de-risk studies as early as possible by analyzing data at the macro-level for insights that are not visible when monitoring individual data points/study sites—thereby enabling AbbVie to take early interventions to mitigate potential risks to the patient, the investigator, the data, the study, and the AbbVie business.

The Central Monitor does this by bringing their deep clinical monitoring expertise together with the power of data analytics. The Central Monitor analyzes near-real time aggregate study and operational data for early Key Risk Indicators of potential study risks (i.e. data trends—noncompliance with study protocols, study patient selection, anomalies/outliers, and so on; as well as within different site segments—sites new to clinical research, sites in new countries and underperforming sites etc.) and initiates the appropriate action to fully investigate the data insight so that the appropriate next steps can be taken to mitigate the potential risk.

The Central Monitor works closely with their All-For-One AbbVie cross-functional colleagues (i.e., primary site monitor, safety, data sciences, and clinical study leadership) to ensure that they understand the data insight, the significance of the implications, and the root cause so that the cross-functional team is able to Decide Smart And Sure on the appropriate actions/next steps to mitigate the risk and/or address the issue.

The Central Monitor function is de-centralized and includes team members from across the globe. Central Monitors are responsible for multiple-jurisdiction studies with sites across the globe.

**Responsibilities**:

- Inspect near-real-time aggregate clinical and operational data from multiple sources (eCRF, vendor data, digital health/wearables, etc.). Utilize data analytics and visualizations to uncover insights and see complex patterns within data to perform review.
- Use Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) to identify significant issues and emerging risks at the study site, program, and country level.
- Clearly document detected issue / emerging risk.
- Translate the issue / emerging risk—the situation, the significance / implication of the data insight, and what further action is required—breaking down complex concepts into simple language.
- Communicate findings as per planned process to ensure that all cross-functional stakeholders have the same understanding of the issue / emerging risk so that the appropriate follow-up action can be taken.
- Arm the primary site monitor with important information that will enable AbbVie to be the clinical partner of choice; allowing monitors to work differently with site staff and have more productive discussions with our Investigator partners.
- Work collaboratively in the pursuit of quality with the primary site monitor, the Study Team and cross-functional departments.
- Participate in Health of Study & Risk Management Meetings.
- Contribute to the ongoing development / advancement / improvement of the RBM systems—providing requirements that will further enable data analysis (i.e. what to look for, how to best present the data so that you can see what you’re looking forward) and testing the system at the study level to ensure system quality.
- Be an RBQM champion across AbbVie, supporting the execution of RBM processes as part of cross-functional teams spanning the R&D portfolio (all therapeutic areas and phases of development).

**Qualifications** Education & Experience**
- Bachelors degree in related field, may include life sciences, risk-based discipline.
- Minimum of 3 years in clinical research monitoring.
- Experience working in an RBQM-model or similar experience with risk-based environment preferred.
- Demonstrated current in-depth knowledge and understanding/or willingness to learn of appropriate therapeutic indications, regulations, and ICH/GCP guidelines as they relate to the conduct of clinical trials (study management, data management and regulatory operations).
- TA experience preferred in one of the following areas (Neuroscience, Oncology, Immunology, Eye Care, Medical Aesthetics, Women’s Healthcare, GI).

**Analytic & Critical Thinking Skills**
- Ability to evaluate large volumes of data from multiple sources and complex issues from multiple perspectives, to identify and investigate atypical patterns/trends, to conduct root cause analysis, and to effectively raise issues to ALL-FOR-ONE-ABBVIE stakeholders for appropriate corrective action.
- Embraces a curious mind set whilst evaluating data or conducting root cause analysis, asking questions of the data in front of them, not fulfilling preconceptions.
- Ability to use critical


  • Central Monitor

    hace 5 meses


    Ciudad de México Novasyte A tiempo completo

    External Job Description - Job Overview- A Central Monitor is a key skilled and clinically experienced team member of IQVIA Central Monitoring Department. Provides remote project support and assistance across multiple projects, sites and teams and reviews the structured clinical data output with access to medical charts.- Essential Functions:- Perform...

  • Central Monitor School

    hace 7 meses


    Ciudad de México Novasyte A tiempo completo

    Job Overview Manage the execution of the assigned clinical study (ies) from initiation through to closeout. Ensure that clinical study management and project deliverables are on time and is in accordance with standard operating procedures (SOPs), policies and practices. To provide project related support and assistance across multiple projects, sites and...


  • León de los Aldama, Guanajuato, México Diseño Central Sa De Cv A tiempo completo

    Descripción del puesto:Nuestra empresa, Diseño Central, busca contratar a un profesional con experiencia para ocupar el cargo de Gerente de Procesos de Manufactura.Sobre la empresa:Nuestra empresa es una empresa líder en el sector de diseño y fabricación de productos de pintura. Nuestros productos son conocidos por su calidad y durabilidad.Otras...


  • Ciudad de México LinkedIn Limited Listings A tiempo completo

    We are building a global eCommerce powerhouse by prioritising operational efficiency through the use of accurate scaling and technology. With a recent Series C raise of over €80 million and ongoing strategic acquisitions, Razor Group is poised to make a significant impact on the e-commerce industry. Our vision is becoming a reality YOUR ROLE As a Amazon...


  • Ciudad de México, Ciudad de México Sagan A tiempo completo

    Job Title: Systems Alert Specialist ILocation: Remote (CST Time zone)Job Overview: Sagan is seeking a highly organized Systems Alert Specialist I to monitor, triage, and respond to server and network alerts in line with service level agreements. The ideal candidate should have experience in system monitoring and the ability to document alert triage...


  • Puertecito de la Virgen, México Central de gas A tiempo completo $10,000 - $12,000

    La Central de Gas está en búsqueda de un profesional con experiencia para ocupar el cargo de Jefe de operaciones de gas. Este puesto es ideal para aquellos que buscan desafíos y oportunidades de crecimiento en un sector dinámico. En este rol, se requiere liderazgo y habilidades de gestión para garantizar el funcionamiento continuo de las estaciones y...


  • Puertecito de la Virgen, México Central de gas A tiempo completo $10,000 - $12,000

    La Central de Gas está en búsqueda de un profesional con experiencia para ocupar el cargo de Jefe de operaciones de gas. Este puesto es ideal para aquellos que buscan desafíos y oportunidades de crecimiento en un sector dinámico. En este rol, se requiere liderazgo y habilidades de gestión para garantizar el funcionamiento continuo de las estaciones y...


  • Estado de México, Méx. SHIELD GLOBAL SERVICES A tiempo completo

    **MONITORISTA PARA CENTRAL CCTV, GPS y ALARMA** Responsable de vigilar en monitores de central las imagenes y señales que reciben los equipos de videovigilancia (CCTV), rastreadores GPS y Alarma. Responsable de activar las llamadas de emergencia de los procesos y protocolos segun cada cliente. Responsable de recibir todas las llamadas telefonicas de la...


  • Coahuila de Zaragoza, México Farmapronto A tiempo completo

    Farmapronto solicita Guardia de SeguridadEn Farmapronto estamos buscando un profesional para trabajar como Guardia de Seguridad en nuestra sucursal ubicada en Central de Abastos, Iztapalapa. Esta es una excelente oportunidad para aquellos que buscan desempeñar un rol importante en la protección de nuestra propiedad y personal.**Salario y...


  • Ecatepec de Morelos, México Farmacias Del Ahorro A tiempo completo

    Empresa del giro FarmacéuticoFarmacias Del Ahorro busca a un/a profesional responsable y motivado/a para ocupar el puesto de Auxiliar de Farmacia Central en nuestra Sucursal Central de Abastos.Sobre la empresa:Nuestra sucursal es una de las más grandes de la zona, con una variedad de productos y servicios para atender todas las necesidades de nuestros...


  • Ciudad de México, Ciudad de México AIG A tiempo completo

    Claims Analyst I Job DescriptionAmerican International Group, Inc. (AIG) is a leading global insurance organization seeking a Claims Analyst I to join our team. As a Claims Analyst I, you will play a crucial role in the claims process, working closely with our business segments to deliver exceptional customer service and support.Key Responsibilities:Review...


  • Puertecito de la Virgen, México Central de gas A tiempo completo $10,000 - $12,000

    Buscamos a un talentoso Jefe de operaciones de gas para unirse a nuestro equipo en la Central de Gas. Si eres un profesional con pasión por el liderazgo y la gestión, y tienes experiencia en el sector de distribución de gas natural, queremos conocerte.Responsabilidades:Liderar y supervisar a un equipo de trabajadores para garantizar el funcionamiento...


  • Puertecito de la Virgen, México Central de gas A tiempo completo $10,000 - $12,000

    Buscamos a un talentoso Jefe de operaciones de gas para unirse a nuestro equipo en la Central de Gas. Si eres un profesional con pasión por el liderazgo y la gestión, y tienes experiencia en el sector de distribución de gas natural, queremos conocerte.Responsabilidades:Liderar y supervisar a un equipo de trabajadores para garantizar el funcionamiento...


  • Ciudad de México, CDMX Parexel A tiempo completo

    The Site Activation Partner I (SAP I) is responsible for leading or supporting operational activities from start up to close out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and client standards. Responsibility within a country and may span over more...

  • Claims Specialist I

    hace 1 mes


    Ciudad de México, Ciudad de México Everest, Consultoría, Administración y Back Office S de RL de CV A tiempo completo

    Job SummaryWe are seeking a highly skilled Claims Specialist I to join our team at Everest, Consultoría, Administración y Back Office S de RL de CV. The successful candidate will be responsible for handling and analyzing mainstream and complex general insurance claims of all varieties, with a special focus on property, financial lines, and liability...


  • Ciudad de México, Ciudad de México Sagan A tiempo completo

    Job Title: Systems Alert Specialist ILocation: Remote (CST Time zone)Salary Range: up to 5000 USDWork Schedule: Monday - Friday, 8:00 AM to 5:00 PM (CST)Job Overview: Sagan is an exclusive membership community for top executives and CEOs seeking to hire and maximize the impact of international talent.Key Responsibilities:Monitor and respond to server and...


  • Naucalpan de Juárez, México Fagron (Central De Drogas, S.A. De C.V.) A tiempo completo

    Fagron es una líder global en compuestos farmacéuticos con presencia en más de 60 países y clientes en todo el mundo. Nuestro propósito es crear un futuro de medicina personalizada.Buscamos a un profesional experimentado para ocupar el puesto de Gerente de Operaciones de Logística en nuestra sede en Naucalpan, México. Este cargo tendrá un papel...


  • Ciudad de México, Ciudad de México Everest, Consultoría, Administración y Back Office S de RL de CV A tiempo completo

    About the Role:Everest, a member of Everest Re Group, Ltd., seeks a Claims Resolution Specialist I to join our team in Mexico.Job Summary:This role involves handling and analyzing mainstream and complex general insurance claims of all varieties, with a special focus on property, financial lines, and liability claims.Key Responsibilities:Manage and analyze...


  • Ciudad de México Santander A tiempo completo

    Gte Risk MI Modelo Informaci I Country: Mexico Somos Grupo Financiero Santander México, SAB de CV (Santander México) Uno de los principales Grupo Santander es el banco líder que, a través de más de 160 años de reinvención, ha llegado a ser una organización sin fronteras con presencia en más de 40 países, 95 nacionalidades y equipos...


  • Cuajimalpa de Morelos (Ciudad de México) Cronoshare.com.mx A tiempo completo

    Necesito un servicio de Hacer instalación eléctrica para obra nueva con las siguientes características:¿Qué tipo de trabajo eléctrico se necesita?   Desmontar reinstalar istalcion eléctrica material i zonaTipo de inmueble donde se realizará el trabajo   Local comercialIndica los m2 del inmueble   Entre 30 y 60 m2¿Qué servicios se...