Site Manager

hace 7 días

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 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 Interfaces:
Investigators and their delegates at site (trial site personnel).

Qualifications:


A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.

Specific therapeutic area experience may be required depending on the position.


Strong working knowledge of GCP, company SOPs, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.

Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home.

Proficient in speaking and writing the country language and English. Good written and oral communication.

  • site manager

    hace 3 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 1 mes

    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 7 días

    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...

  • Site Manager

    hace 7 días

    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 7 días

    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 7 días

    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 7 días

    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 7 días

    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 7 días

    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 7 días

    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 7 días

    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 7 días

    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 7 días

    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...

  • Senior Site Manager

    hace 7 días

    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 7 días

    Madrid, Madrid, España Eosol Group A tiempo completo

    EOSOL, fundada en el año 2008 en Pamplona (España) es un grupo de empresas de servicios que ofrece servicios de ingeniería, supervisión y O&M. Con experiência en más de 40 países alrededor del mundo, operamos en sectores estratégicos como son Energía, Industria, Automoción, Edificación e Infraestructuras, Telecomunicaciones, Aeroespacial y...

  • Expert Site Manager gifts

    hace 7 días

    Madrid, Madrid, España Johnson & Johnson A tiempo completo

    Global Clinical Operations (GCO)Position Title: Site Manager IIIPosition 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...

  • Associate Manager, Site Agreements

    hace 7 días

    Madrid, Madrid, España Pharmiweb A tiempo completo

    As a top global contract research organization (CRO) with a strong focus on scientific accuracy and extensive experience in clinical development, Fortrea offers pharmaceutical, biotechnology, and medical device clients a variety of solutions in clinical development, patient access, and technology across more than 20 therapeutic areas. With a workforce of...

  • Site Manager Facility

    hace 7 días

    Madrid, Madrid, España Page Personnel España A tiempo completo

    Experiência en gestión de servicios FM /mantenimiento integral asegurando el cumplimiento de la planificación de preventivos y rápida gestión de correctivos. Gestión de equipo Gran capacidad de interlocución con cliente/ usuarios. Gestión y control de proveedores Seguimiento económico: gestión de pedidos, facturación, control de presupuestos,...

  • Site Manager Logística

    hace 7 días

    Madrid, 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...

  • Associate Manager, Site Agreements

    hace 7 días

    Madrid, Madrid, España ESP Labcorp Development S.A.U. 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...