Ed&cp Site Manager I

hace 1 semana

Madrid, Madrid, España Johnson & Johnson A tiempo completo

For More Than 130 Years, Diversity, Equity & Inclusion (DEI) Have Been Part Of Our Cultural Fabric At Johnson & Johnson And Woven Into How We Do Business Every Day.

Our Commitment To Respect The Dignity And Diversity Of All Is Embedded In Our Credo.

We Know That The Success Of Our Business Depends On Having The Best Talent In A Workforce That Reflects The Diverse Markets We Serve Around The World And An Inclusive Culture That Values Different Perspectives And Life Experiences


That Is Why We In Spain Are Working To Create An Inclusive Environment Where Diverse Backgrounds, Perspectives And Experiences Are Valued And Each And Every One Of Our People Feels That They Belong And Can Reach Their Potential.

No Matter Who They Are.

Diversity, Equity & Inclusion At Johnson & Johnson Means "You Belong"

A Site Manager I may contribute to process improvement and training.

Principal Responsibilities:

- (List Major Responsibilities and duties of the position. Describe scope of responsibilities.) _

  • Participates in site assessments, conducts pretrial site assessment visits and/or participates to study feasibility assessments, providing recommendation from local area about site/investigator selection in collaboration with the trial team
  • Acts as primary contact for assigned sites for specific ED&CP trials and works closely with TM and trial central team regarding study progress and issue resolution.
  • Attends/participates in investigator meetings as needed.
  • Responsible for executing activities within site initiation and startup, site monitoring, site management and site/study closeout per internal SOPs, other procedural documents and policies.
  • Ensures site staff have current GCP and necessary protocol, compound and systems training to conduct the clinical trial. Complete retraining when needed. Ensure training records are filed at sites and sponsor level.
  • Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
  • Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct.
  • In collaboration with Site Investigational Product Specialist (SIPS) and Pharmacy Investigational Product Specialist (PIPS), ensures that clinical drug supplies are appropriately handled, administered and stored. Ensure strict adherence to investigational product preparation and administration guidelines. Ensures clinical drug supplies are appropriately inventoried, accounted and returned as applicable including maintenance of accurate and complete documentation.
  • Ensures site staff complete the data entry and resolve queries within expected timelines. Set up plan to improve data entry in collaboration with TM when needed.
  • Ensures accuracy, validity and completeness of data collected at trial sites. Ensure appropriate measures are in place for maintenance of the blind when applicable
  • Ensures that all Adverse Events (AEs)/Serious Adverse events (SAEs)/Product Quality Complaints (PQC) are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensure that they are consistent with all data collected and with the information in the source documents.
  • Maintains complete, accurate and timely data and essential documents in systems utilized for trial management.
  • Fully documents trial related activities with respect to study monitoring. Writes visit reports and address followup letters to investigators within procedural timelines. Responsible for documentation and escalation of major deviations and issues to appropriate stakeholders. Ensures timely corrective actions are completed and documented.
  • Reviews investigator site file for completeness and ensures archiving retention requirements, including storage in a secure area at all times.
  • Collaborates with TM for documenting and communicating site/study progress and issues to trial central team.
  • Attends regularly scheduled team meetings and trainings.
  • Complies with relevant training requirements. Acts as local expert in assigned protocols. Develops sufficient therapeutic area and early development knowledge to support roles and responsibilities. Works across therapeutic areas dependent upon ED&CP business needs.
  • Works closely with TM to ensure Corrective Action Preventive Action (CAPA) is completed for QA site audits or Inspection and for quality issues identified at the site during routine monitoring and other visit types, e.g., On Site Quality Monitoring visit (OSQMV).
  • Prepares trial sites for close out, conduct final close out visit.
  • May review and manage site specific informed consent forms in accordance with GCO SOPs, procedural documents and applicable regulations.
  • May participate in the HA and IEC/IRB submission and notification processes as required/appropriate.
  • Tracks costs at site level and ensure payments are made, if applicable or collaborates with C&G in charge of si

  • Ed&cp Regional Site Strategy Lead

    hace 1 semana

    Madrid, Madrid, España Johnson & Johnson A tiempo completo

    Position Summary:The Early Development and Clinical Pharmacology (ED&CP) Regional Site Strategy Lead (SSL) is accountable for the strategy to build and leverage investigator site capabilities and capacity for ED&CP trials in designated area / countries. This role will support program and study level country / site recommendations during feasibility and...

  • Regional Site Strategy Lead Gco Ed&cp Oncology

    hace 1 semana

    Madrid, Madrid, España Johnson & Johnson A tiempo completo

    Position Summary:The Early Development and Clinical Pharmacology (ED&CP) Regional Site Strategy Lead (SSL) is accountable for the strategy to build and leverage investigator site capabilities and capacity for ED&CP trials in designated area / countries. This role will support program and study level country / site recommendations during feasibility and...

  • Regional Site Strategy Lead Gco Ed&Cp Oncology

    hace 1 semana

    Madrid, Madrid, España Johnson And Johnson A tiempo completo

    Position Summary: The Early Development and Clinical Pharmacology (ED&CP) Regional Site Strategy Lead (SSL) is accountable for the strategy to build and leverage investigator site capabilities and capacity for ED&CP trials in designated area / countries.This role will support program and study level country / site recommendations during feasibility and...

  • Regional Site Strategy Lead Gco Ed&Cp Oncology

    hace 1 semana

    Madrid, Madrid, España Johnson & Johnson A tiempo completo

    Job Description - Regional Site Strategy Lead GCO ED&CP Oncology W) Regional Site Strategy Lead GCO ED&CP Oncology W Description Position Summary: The Early Development and Clinical Pharmacology (ED&CP) Regional Site Strategy Lead (SSL) is accountable for the strategy to build and leverage investigator site capabilities and capacity for ED&CP trials in...

  • Senior Site Manager

    hace 1 semana

    Madrid, Madrid, España Johnson & Johnson A tiempo completo

    Senior Site Manager, Early Development & Clinical Pharmacology:We are looking for a Senior Site Manager, Early Development & Clinical Pharmacology (ED&CP) to serve as the primary contact point between the Sponsor and the Investigational Site for the conduct of complex early development and/or clinical pharmacology studies. In other organisations, the Site...

  • site manager

    hace 4 semanas

    Madrid, Madrid, España J&J Family of Companies A tiempo completo

    SITE MANAGER WDescriptionPosition Summary:A Site Manager I (SM I) serves as the primary contact point between the Sponsor and the Investigational Site. A Site Manager I is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and...

  • site manager

    hace 2 meses

    Madrid, Madrid, España J&J Family of Companies A tiempo completo

    SITE MANAGER WDescriptionPosition Summary:A Site Manager I (SM I) serves as the primary contact point between the Sponsor and the Investigational Site. A Site Manager I is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and...

  • site manager

    hace 1 semana

    Madrid, Madrid, España MCR International | Executive Search A tiempo completo

    SITE MANAGERBarcelonaBarcelona, Catalonia, ESASPSITE MANAGERBARCELONADesde MCR International estamos buscando un Site Manager para trabajar en una multinacional del sector Gran Consumo . Va a reportar al Director de I+D. Dirigirás un equipo de más de 20 personas. Al mismo tiempo, colaborará estrechamente con otras áreas de I+D, como Investigación y...

  • Cell Therapy Site Manager

    hace 1 semana

    Madrid, Madrid, España Bristol-Myers Squibb A tiempo completo

    Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...

  • Site Manager

    hace 1 semana

    Madrid, Madrid, España Johnson & Johnson A tiempo completo

    Position Summary:Principal Responsibilities:Acts as primary local company contact for assigned sites for specific trials.May participate in site feasibility and/or pre-trial site assessment visitsAttends/participates in investigator meetings as needed.Responsible for executing activities within site initiation and start-up, preparation and conduct of site...

  • Site Manager

    hace 1 semana

    Madrid, Madrid, España Igneoingenieria A tiempo completo

    DescripciónSite Manager de instalaciones renovables y de eficiencia energética.TareasGestión Integral del proyecto:Interlocución con el clienteRedacción de informes de avance (plazo, coste, calidad)Gestión del equipo de Oficina Técnica y On Site. Coordinación del equipoEspecificar la calidad de cada parte entregable.Estimar los recursos y los plazos...

  • Site Manager Planta

    hace 1 semana

    Madrid, Madrid, España Grupoeosol A tiempo completo

    Oferta de Empleo: Site Manager Planta Perú Descripción del Trabajo:Eosol Group, empresa líder en el sector de energía renovable, está en la búsqueda de un Site Manager para la planta solar fotovoltaica de Illa en Perú. El Site Manager será el responsable de la ejecución de proyectos en la planta, asegurando que se cumplan los objetivos y estándares...

  • Site Manager Planta

    hace 1 semana

    Madrid, Madrid, España Grupoeosol A tiempo completo

    Oferta de Empleo: Site Manager Planta - PerúDescripción del Trabajo: Eosol Group, empresa líder en el sector de energía renovable, está en la búsqueda de un Site Manager para la planta solar fotovoltaica de Illa en Perú. El Site Manager será el responsable de la ejecución de proyectos en la planta, asegurando que se cumplan los objetivos y...

  • Sr Site Manager

    hace 1 semana

    Madrid, Madrid, España Johnson & Johnson A tiempo completo

    Global Clinical Operations (GCO)Position Title: Site Manager II(12 positions available)Position Summary:Principal Responsibilities:Acts as primary local company contact for assigned sites for specific trials.May participate in site feasibility and/or pre-trial site assessment visitsAttends/participates in investigator meetings as needed.Responsible for...

  • Site Manager Planta

    hace 1 semana

    Madrid, Madrid, España Eosol Group A tiempo completo

    Descripción Oferta de Empleo: Site Manager Planta PerúDescripción del Trabajo:Eosol Group, empresa líder en el sector de energía renovable, está en la búsqueda de un Site Manager para la planta solar fotovoltaica de Illa en Perú. El Site Manager será el responsable de la ejecución de proyectos en la planta, asegurando que se cumplan los objetivos y...

  • Site Manager Planta

    hace 1 semana

    Madrid, Madrid, España Eosol Group A tiempo completo

    Descripción Oferta de Empleo: Site Manager Planta - PerúDescripción del Trabajo:Eosol Group, empresa líder en el sector de energía renovable, está en la búsqueda de un Site Manager para la planta solar fotovoltaica de Illa en Perú. El Site Manager será el responsable de la ejecución de proyectos en la planta, asegurando que se cumplan los objetivos...

  • Site Manager Planta

    hace 1 semana

    Madrid, Madrid, España Eosol Group A tiempo completo

    Oferta de Empleo: Site Manager Planta - PerúDescripción del Trabajo:Eosol Group, empresa líder en el sector de energía renovable, está en la búsqueda de un Site Manager para la planta solar fotovoltaica de Illa en Perú. El Site Manager será el responsable de la ejecución de proyectos en la planta, asegurando que se cumplan los objetivos y...

  • Site Manager

    hace 1 semana

    Madrid, Madrid, España De Keizer Marine Engineering A tiempo completo

    For our location on Palma de Mallorca, Spain, we are looking for a new Site Manager.As a site manager, you have the final responsibility for having a great team which realizes our Palma projects and service orders.You have to do a variety of tasks such as team development, calculations, engineering, coordination and many many more.Next to this, you will be...

  • Site Manager

    hace 1 semana

    Madrid, Madrid, España Guysinred A tiempo completo

    For our location on Palma de Mallorca, Spain, we are looking for a new Site Manager.As a site manager, you have the final responsibility for having a great team which realizes our Palma projects and service orders. You have to do a variety of tasks such as team development, calculations, engineering, coordination and many many more. Next to this, you will be...

  • Site Manager

    hace 1 semana

    Madrid, Madrid, España Boss Energy Consulting A tiempo completo

    Site Manager SpainOur client is a market leading business within the renewable energy industry. With over 20 years of experience and offering services across the full value chain, our client has a proven track record in the development and construction of large-scale solar systems across the globe As a site manager, you will be responsible for on-site...