Site Manager Multi-tumour

hace 7 meses

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 3 horas

    Madrid, España Siemens Gamesa Renewable Energy, S.A. A tiempo completo

    .It takes the brightest minds to be a technology leader. It takes imagination to create green energy for the generations to come. At Siemens Gamesa we make real what matters, join our global team.Siemens Gamesa Renewable Energy (SGRE) is the world market leader in offshore wind energy and with our innovations, SGRE wants to make a difference for wind energy...

  • Site Manager

    hace 7 meses

    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 Logistics Manager

    hace 1 semana

    Madrid, España Alandale Logistics Ltd A tiempo completo

    We have an exciting opportunity for a Site Logistics Manager with experience for our site based in Madrid, Spain. This position will require you to speak fluent Spanish. The role of a site Logistics Manager is to supervise and work with various office and on-site supervisors/operatives to plan, organise, and implement the logistics, traffic, security and...

  • Site Manager Logística

    hace 7 meses

    Madrid, España LHH A tiempo completo

    Desde LHH estamos buscando un Site Manager/ Director/a de Centro Logístico para un/a importante operador/a líder en servicios de logística en España y Portugal. La persona seleccionada reportará al COO y tendrá las funciones de Supervisar las siguientes posiciones: Responsable Almacén, Responsable X-Dock, Responsable Tráfico, Responsable Customer...

  • Senior Site Manager

    hace 4 meses

    Madrid, España Johnson & Johnson A tiempo completo

    Global Clinical Operations (GCO) Senior Site Manager (1/2) Position Summary: Principal Responsibilities: 1 Acts as primary local company contact for assigned sites for specific trials. 2 Actively May participate in site feasibility and/or Site Qualification Visit. 3 Attends/participates in investigator meetings as needed, may be expected to help prepare...

  • Site Manager

    hace 7 días

    Madrid, España Tecnicas Reunidas A tiempo completo

    Técnicas Reunidas group (TR) is a leading Oil & Gas International Engineering and Construction Company specialized in the design, construction and management of execution of Industrial plants worldwide.We also participate in projects related to hydrogen, biomass, biofuels, decarbonisation, artificial intelligence, digitization.The sustainable growth,...

  • Site Manager

    hace 1 día

    Madrid, España Tecnicas Reunidas A tiempo completo

    Técnicas Reunidas group (TR) is a leading Oil & Gas International Engineering and Construction Company specialized in the design, construction and management of execution of Industrial plants worldwide. We also participate in projects related to hydrogen, biomass, biofuels, decarbonisation, artificial intelligence, digitization. The sustainable growth,...

  • Site Manager

    hace 8 horas

    Madrid, España Tecnicas Reunidas A tiempo completo

    Técnicas Reunidas group (TR) is a leading Oil & Gas International Engineering and Construction Company specialized in the design, construction and management of execution of Industrial plants worldwide. We also participate in projects related to hydrogen, biomass, biofuels, decarbonisation, artificial intelligence, digitization. The sustainable growth,...

  • Site Manager

    hace 1 semana

    Madrid, España Enel A tiempo completo

    Site Manager (MAD1Z1) ¿Qué se hace en la Business Line y en la unidad? Dentro del area de Ingenieria y Construccion, la unidad de Renewable Project Execution / Repowering and Refurbishment gestiona en todo el mundo la ejecución de proyectos de renovación y repotenciamiento de las plantas existentes hasta el hand-over a O&M, coordinando los equipos de...

  • Site Manager

    hace 3 semanas

    Madrid, España Tecnicas Reunidas A tiempo completo

    Técnicas Reunidas group (TR) is a leading Oil & Gas International Engineering and Construction Company specialized in the design, construction and management of execution of Industrial plants worldwide. We also participate in projects related to hydrogen, biomass, biofuels, decarbonisation, artificial intelligence, and digitization. The sustainable growth,...

  • Csa Site Manager

    hace 5 meses

    Madrid, España H&MV Engineering A tiempo completo

    **Position Description**: CSA Site Manager **Reports**: Construction Manager Location : Zaragoza **About H&MV Engineering**: H&MV Engineering Services is part of the industry leading, award-winning global H&MV Engineering group which was established in Ireland in 1997. The company is a leader in providing engineering solutions across a broad range of...

  • Site Manager

    hace 7 meses

    Madrid, España Galp A tiempo completo

    Working at Galp is about bringing more energy to the world. It is having the ambition to build the future in a sector that is going through a deep transformation. It is being part of a team where we believe our people can achieve their full potential. We value and encourage a leadership that is able to promote change, confidence, and talent, with a work...

  • Site Manager Planta

    hace 7 meses

    Madrid, España Eosol Group A tiempo completo

    **Descripción 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...

  • Senior Site Manager Ez-692

    hace 1 día

    Madrid, España Reconocida Empresa A tiempo completo

    .Johnson & Johnson is currently seeking a Senior Site Manager to join our team located in France.A Senior Site Manager serves as the primary contact point between the Sponsor and the Investigational Site.A Senior Site Manager is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard...

  • Site Manager Logística

    hace 6 meses

    Madrid, España Lhh A tiempo completo

    Desde LHH estamos buscando un Site Manager/ Director/a de Centro Logístico para un/a importante operador/a líder en servicios de logística en España y Portugal.La persona seleccionada reportará al COO y tendrá las funciones de Supervisar las siguientes posiciones: Responsable Almacén, Responsable X-Dock, Responsable Tráfico, Responsable Customer...

  • Site Manager Planta

    hace 7 meses

    Madrid, España Eosol Group A tiempo completo

    **Descripción 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...

  • Site Manager Instalaciones

    hace 7 meses

    Madrid, España onhunters A tiempo completo

    Descripción Desde **onhunters **estamos buscando un/a **SITE MANAGER **con experiência en instalaciones y en proyectos a nível internacional. Ubicación: Caribe Tipo de contrato: indefinido Modalidad: Presencial 100% **POSICIÓN**: Como **SITE MANAGER, **supervisarás los costes y ejecución de los trabajos y propondrás mejoras. Reportando al...

  • Site Manager

    hace 1 semana

    Madrid, España Tecnicas Reunidas A tiempo completo

    Técnicas Reunidas group (TR) is a leading Oil & Gas International Engineering and Construction Company specialized in the design, construction and management of execution of Industrial plants worldwide. We also participate in projects related to hydrogen, biomass, biofuels, decarbonisation, artificial intelligence, digitization.The sustainable growth,...

  • Site Manager

    hace 1 semana

    Madrid, España Tecnicas Reunidas A tiempo completo

    Técnicas Reunidas group (TR) is a leading Oil & Gas International Engineering and Construction Company specialized in the design, construction and management of execution of Industrial plants worldwide. We also participate in projects related to hydrogen, biomass, biofuels, decarbonisation, artificial intelligence, digitization.The sustainable growth,...

  • Site Manager

    hace 7 meses

    Madrid, España Galp A tiempo completo

    Galp is an energy company committed to develop efficient and sustainable solutions in its operations and in the integrated offers provided to its clients. We create simple, flexible and competitive solutions for the energy and mobility needs of both industrial and individual consumers. Our portfolio includes multiple types of energy - from renewable...