Clinical Trial Lead

hace 3 semanas


Sant Cugat del Vallès Barcelona provincia, España Boehringer Ingelheim España, S.A. A tiempo completo

El/la Clinical Trial Leader es responsable de la gestión operativa de los ensayos clínicos a nível internacional (nível trial) desde la fase de preparación e inicios hasta el cierre de la base de datos y elaboración del informe final. Se encarga de asegurar la viabilidad del estudio, así como los plazos, presupuesto y calidad de los datos, alineando para ello al trial team y a los diferentes países participantes del estudio.
También es garante de que el ensayo se desarrolle observando estrictamente los principios GCP y la legislación y regulaciones internas así como las de aplicación en cada país según corresponda, debe evaluar proactivamente los riesgos del ensayo y diseña e implementa acciones y planes destinados a mitigarlos.

***Funciones & Responsabilidades**:

- Desarrollar y ejecutar exitosamente la gestión de los ensayos clínicos bajo su responsabilidad.
- Desarrollar y dirigir la implementación de los planes de risk management and mitigation.
- Coordinar las diferentes funciones que conforman el trial team a nível internacional.
- Coordinar los CTMs y supervisar la actividad de los diferentes países que participan en el estudio
- Trabajar con todas las funciones y vendors para asegurar que todos los procesos y materiales necesarios para los estudios están listos antes del inicio del estudio y asegurar su correcto funcionamiento a lo largo del mismo.
- Proveer las herramientas necesarias para facilitar la submission y dar apoyo durante el proceso de evaluación y aprobación de los estudios en todos los países participantes.
- Planificar y controlar el stock de medicación necesario para el estudio en colaboración con CTSU.
- Elaboración del protocolo en colaboración con otras funciones como TMM, CTPh, TSTAT...
- Elaboración del informe final y posibles informes interinos del estudio en estrecha colaboración con el MW (si aplica).
- Responsable del archivo del ensayo (TMF) a nível internacional.
- Colaborar con las diferentes publicaciones del ensayo en revistas científicas, congresos, y otros eventos de carácter científico.
- Participación activa en distintos foros funcionales (MST, CTL fórum )

**Perfil & Requisitos**:

- Licenciatura en ciencias de la salud (farmacia, biología, medicina, etc.)
- Experiência previa mínima de 5 años en la industria farmacéutica gestionando ensayos clínicos.
- Nível alto de inglés.
- Conocimiento de regulación de ensayos clínicos y Buena Práctica Clínica (GCP)
- Excelentes habilidades de gestión de proyectos y de organización
- Habilidades de comunicación verbal y escrita, especialmente en inglés.
- Alta capacidad de trabajo en equipos multiculturales.
- Capacidad de liderazgo e influencia. Persona con foco en el paciente y en el investigador y en el entendimiento de sus necesidades

IamBoehringerIngelheim porque

Estamos continuamente trabajando porque queremos diseñar para ti la mejor experiência. Estos son algunos ejemplos de cómo te cuidaremos:

- Horario flexible
- Seguro de vida y accidente
- Seguro médico a un precio competitivo
- Inversión en formación y desarrollo
- Cuidado de la salud
- Portal de ofertas para colaboradores
- Smartworking

Si has leído hasta aquí, ¿qué esperas para aplicar? Queremos saber más de ti



  • Sant Cugat del Vallès, España Grifols A tiempo completo

    ¿Te gustaría unirte a un equipo internacional que trabaja para mejorar el futuro del sector de la salud? ¿Quieres contribuir a mejorar la vida de millones de personas? Grifols es una compañía global del sector de la salud que desde 1909 mejora la salud y el bienestar de las personas en todo el mundo. Somos líderes en medicamentos hemoderivados y...


  • Barcelona, España Syneos Health Clinical A tiempo completo

    **Description** **Clinical Trial Supplies Mgr** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our...


  • Barcelona, España Syneos Health Clinical A tiempo completo

    **Description** **Senior Clinical Trial Manager** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help...


  • Barcelona, España Syneos Health Clinical A tiempo completo

    **Description** **Clinical Trial Manager, Investigator Sponsored Studies - Home Based in Italy or Spain** The role is Sponsor dedicated. Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address...


  • Barcelona, España Syneos Health Clinical A tiempo completo

    **Description** **Clinical Trial Manager** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our...


  • Barcelona, España Syneos Health Clinical A tiempo completo

    **Description** **Clinical Trial Manager II** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient...

  • Clinical Trial Manager

    hace 7 días


    Barcelona, España Recruiting Erasmus A tiempo completo

    **AstraZeneca** is an innovation-driven global biopharmaceutical company focused on the discovery, development and commercialization of prescription medicines, primarily for the treatment of cardiovascular, renal and metabolic, respiratory and immunological, oncological and rare diseases. In line with our firm commitment to training and developing...


  • Sant Cugat del Vallès, España AB-Biotics, S.A. A tiempo completo

    AB-Biotics was founded in 2004 as a spin-off of the Autonomous University of Barcelona (UAB), now it is a leading biotechnology company, with an international vocation, and it divides its activities into these two main business areas (probiotics & precision medicine) based on research, development, intellectual protection and the distribution of their own...

  • Clinical Trials Manager

    hace 1 semana


    Sant Cugat del Vallès, España AB-Biotics, S.A. A tiempo completo

    AB-Biotics was founded in 2004 as a spin-off of the Autonomous University of Barcelona (UAB), now it is a leading biotechnology company, with an international vocation, and it divides its activities into these two main business areas (probiotics & precision medicine) based on research, development, intellectual protection and the distribution of their own...

  • Clinical Trials Manager

    hace 1 semana


    Sant Cugat del Vallès, España AB-Biotics, S.A. A tiempo completo

    AB-Biotics was founded in 2004 as a spin-off of the Autonomous University of Barcelona (UAB), now it is a leading biotechnology company, with an international vocation, and it divides its activities into these two main business areas (probiotics & precision medicine) based on research, development, intellectual protection and the distribution of their own...


  • Sant Cugat del Vallès, España Grifols A tiempo completo

    For more than 75 years, Grifols has worked to improve the health and well-being of people around the world. We are a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care. Headquartered in...

  • (Fnc) Lbp

    hace 2 días


    Barcelona, España Cti Clinical Trial Services A tiempo completo

    . CTI Clinical Trial Services, Inc - Madrid, Spain Details Negotiable Freelancer 1 position Administrator, Clinical MonitoringJob Purpose/SummaryResponsible for supporting the Clinical Monitoring department, the CRA Management team, and the Vice President of Global Clinical Monitoring, focusing on administrative responsibilities. What You'll DoProvide...


  • Barcelona, España Syneos - Clinical and Corporate - Prod A tiempo completo

    **Description** Sponsor Dedicated Clinical Trial Manager II/ Sr CTM - Home Based in SPAIN **Experience as CTM in the management of global/multiple-countries studies and different types of vendors is required.** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique...


  • Barcelona, España Amgen A tiempo completo

    Career Category Clinical Development **Job Description**: HOW MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are! At Amgen, our shared mission—to serve patients—drives all that we do, which is the key for us to becoming one of the world’s leading biotechnology companies. We are global...

  • Clinical QA Trainee

    hace 12 horas


    Sant Cugat del Vallès, España Grifols A tiempo completo

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and...


  • Barcelona, España Neuroelectrics A tiempo completo

    **Who we are**: Neuroelectrics is a creative, high-tech company offering the best-in-class non-invasive and high-definition electrical brain stimulation technology for personalized neuromodulation. By measuring and modifying brain function, we aim to restore brain health, minimize disabilities and create a better life for patients. We are looking for new...


  • Barcelona, España Vall d'Hebron Institute of Oncology (VHIO) A tiempo completo

    27 December 2021 **El Vall d´Hebron Institute of Oncology (VHIO) busca un/a “**Clinical Trial Assistant**”** **Referencia**:Ref. 45-2021 **Nº de plazas**:1 **Descripción de la oferta**: Para la CRO académica del VHIO buscamos a un/a CTA (Clinical Trial Assistant) con perfil Administrativo/a o Aux. administrativo/a. Necesitamos a una persona...

  • Clinical Associate

    hace 1 día


    Barcelona, España ICON Clinical Research A tiempo completo

    • Recognize, exemplify and adhere to ICON's values which center around our culture of accountability, integrity, partnership, collaboration and excellence in delivery. • As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business...


  • Barcelona, España ICON A tiempo completo

    At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...


  • Barcelona, España Almirall Hermal Gmbh A tiempo completo

    Mission• The Global Clinical Program Lead (GCPL) is a core member of the Global Project Team and is leading the Strategic Clinical Team within Global Clinical Development, working cross functionally with other R&D and non-R&D departments such as Regulatory and Patient Safety, Disease Biology, Global Market Access and Pricing, Medical affairs, Marketing,...