Site Manager Multi-tumour

hace 2 semanas

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 (SM I) serves as the primary contact point between the Sponsor and the Investigational Site.

**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 visits
- Attends/participates in investigator meetings as needed.
- Responsible for executing activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies.Responsible for the implementation of analytical risk based monitoring model at the site level and to work with site to ensure timely resolution of issues found during monitoring visits.
- Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with LTM and central study team for the activities during site activation phase in order to speed up the process and activate the site in shortest possible timeframe.
- Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas.
- Ensures site study supplies (such as Non-Investigational Product (IP), lab kits, etc.) are adequate for trial conduct.
- Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented.
- Arranges for the appropriate destruction of clinical supplies.
- Ensures site staff complete data entry and resolve queries within expected timelines.
- Ensures accuracy, validity and completeness of data collected at trial sites
- Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs )/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures 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 relevant systems utilized for trial management.
- Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders.
- Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times.
- Collaborates with LTM 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. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities.
- Works closely with LTM to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits 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.
- Tracks costs at site level and ensure payments are made, if applicable.
- Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff.
- May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate.
- Acts as a point of contact in site management practices.
- May contribute to process improvement and training.

**Principal Relationships**:
Primary Reporting Structure: Reports to a Functional Manager
Primary interfaces: Functional Manager, CTA, LTM and CTM.
Other Internal Interfaces: R&D Country Head, Therapeutic Area Manager/Physician, Quality & Compliance Manager/Specialist, Training Manager, Contracts & Grants, Local Drug Safety Officer (where required) and Site Manager team.
External Interfa

  • Site Manager

    hace 8 horas

    Madrid, España Johnson And Johnson A tiempo completo

    Position 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 applicable regulations...

  • site manager

    hace 2 días

    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 3 días

    Madrid, España Johnson & Johnson A tiempo completo

    **Position Summary**: **Principal Responsibilities**: 1. Acts as primary local company contact for assigned sites for specific trials. 2. May participate in site feasibility and/or pre-trial site assessment visits 3. Attends/participates in investigator meetings as needed. 4. Responsible for executing activities within site initiation and start-up,...

  • Site Manager

    hace 2 semanas

    Madrid, España Igneo Ingeniería Sostenible S.L.U. A tiempo completo

    Descripción Site Manager de instalaciones renovables y de eficiencia energética. Tareas Gestión Integral del proyecto: Interlocución con el cliente Redacción de informes de avance (plazo, coste, calidad) Gestión del equipo de Oficina Técnica y On Site. Coordinación del equipo Especificar la calidad de cada parte entregable. Estimar los recursos y los...

  • Senior Site Manager

    hace 3 días

    Madrid, España Johnson & Johnson A tiempo completo

    Position Summary: (Position 1/2) A Site Manager II (SM II) serves as the primary contact point between the Sponsor and the Investigational Site. A Site Manager II 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, España Igneo Ingeniería Sostenible S.L.U. A tiempo completo

    Descripción Site Manager de instalaciones renovables y de eficiencia energética. Tareas Gestión Integral del proyecto: Interlocución con el cliente Redacción de informes de avance (plazo, coste, calidad) Gestión del equipo de Oficina Técnica y On Site. Coordinación del equipo Especificar la calidad de cada parte entregable. Estimar los recursos y los...

  • Sr Site Manager

    hace 4 semanas

    Madrid, España Johnson & Johnson A tiempo completo

    **Global Clinical Operations (GCO)** **Position Title: Site Manager II** **(12 positions available)** **Position Summary**: **Principal Responsibilities**: 1. Acts as primary local company contact for assigned sites for specific trials. 2. May participate in site feasibility and/or pre-trial site assessment visits 3. Attends/participates in investigator...

  • Site Manager gifts

    hace 4 semanas

    Madrid, España Johnson & Johnson A tiempo completo

    **Global Clinical Operations (GCO)** **Position Title: Site Manager I** **(2 positions available)** **Position Summary**: **Principal Responsibilities**: 1. Acts as primary local company contact for assigned sites for specific trials. 2. May participate in site feasibility and/or pre-trial site assessment visits 3. Attends/participates in investigator...

  • Site Manager

    hace 2 semanas

    Madrid, España Igneo Ingeniería Sostenible S.L.U. 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...

  • Expert Site Manager gifts

    hace 4 semanas

    Madrid, España Johnson & Johnson A tiempo completo

    **Global Clinical Operations (GCO)** **Position Title: Site Manager III** Position Summary: **Principal Responsibilities**: 1. Acts as primary local company contact for assigned sites for specific trials. 2. May participate in site feasibility and/or pre-trial site assessment visits 3. Attends/participates in investigator meetings as needed. 4....

  • Associate Manager, Site Agreements

    hace 2 días

    Madrid, España Fortrea A tiempo completo

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Associate Manager, Site Agreements

    hace 2 días

    Madrid, España Fortrea A tiempo completo

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Senior Site Manager

    hace 4 semanas

    Madrid, España Johnson & Johnson A tiempo completo

    **Position Summary**: contribute to process improvement, training and mentoring of other Site Managers. **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 visits - Attends/participates in investigator meetings as needed. -...

  • Site Manager

    hace 6 días

    Madrid, España Capgemini Engineering A tiempo completo

    **¡Te estamos esperando!**: Desde Capgemini Engineering estamos buscando un perfil de SITE MANAGER para unirse a nuestros equipos de Digital! Tus funciones serán: - Responsable de los entornos y equipos desplegados - Responsable del análisis de necesidades del programa/proyecto para cubrir los requerimientos del despliegue, integración e...

  • Site Manager

    hace 4 semanas

    Madrid, Madrid, España Michael Page A tiempo completo

    Importante multinacional especializada en la industria automovilística|Imprescindible experiencia en un puesto de desarrollo de producto y hunterMultinacional especializada en la industria de la automoción desde donde ofrecen servicios completos de ingeniería a nivel mundial.Actualmente se encuentran en búsqueda de un Site Manager para desarrollar...

  • Site Manager

    hace 4 semanas

    Madrid, España ID Energy Group A tiempo completo

    En #IDEnergyGroup apostamos por el talento, creemos en las personas y en su capacidad de superación, y es por ello por lo que fomentamos un crecimiento personal y profesional con igualdad de oportunidades para todos. Nuestro objetivo es crecer con un equipo humano comprometido con la excelencia en el servicio, con motivación e ilusión y alineado con la...

  • Sr. Site Manager Ed&cp

    hace 4 semanas

    Madrid, España Johnson & Johnson A tiempo completo

    **Global Clinical Operations (GCO)** **Position Title: ED&CP Site Manager II** **(4 positions available)** **Position Summary**: **Principal Responsibilities**: 1. Participates in site assessments, conducts pre-trial site assessment visits and/or participates to study feasibility assessments, providing recommendation from local area about...

  • Site Manager

    hace 4 semanas

    Madrid, España Acertto A tiempo completo

    **Descripción**: Seleccionamos **un/a Site & Project manager **para una importante empresa del sector de las energías renovables. Tu **misión principal** será supervisar los aspectos productivos, técnicos, administrativos y de gestión del equipo humano de las obras, vigilando que se cumplan las normativas establecidas y que los proyectos se...

  • Assistant Site Manager – Warehouse Automation

    hace 2 semanas

    Madrid, España Signode A tiempo completo

    Warehouse Automation, WAUTI () supplies fully-integrated warehouse automation solutions across the Globe. The Warehouse Automation product portfolio consists of Storfast deep lane, ultra high density Automated Storage and Retrieval Systems (AS/RS). The Company offers integrated automation solutions for “greenfield” sites or scalable solutions that are...

  • Electrical Site Manager

    hace 4 semanas

    Madrid, España Enertis Applus+ A tiempo completo

    **Enertis Applus+ **es una firma global de Consultoría e Ingeniería, líder en el sector de las energías renovables y soluciones de almacenamiento. Tenemos presencia en más de 65 países, y participación en diferentes asociaciones del sector. Nuestra experiência y «know-how» garantiza soluciones adaptadas a los desafíos y problemas de nuestros...