Study Start-up Intern

hace 2 semanas

Madrid, España Allucent A tiempo completo

These customers have new therapeutic ideas but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in patients’ lives.

The SSU Intern provides administrative support to all activities within Allucent’s Study Start-Up & Site Intelligence unit. This may include tasks related to essential document review, regulatory submission preparation, site contracting activities and Start-up management/oversight and is a member of the Study Start-Up & Site Intelligence unit.

This position is a full time internship and will be based in our office in Madrid.

**Key Requirements**
- Pre-populate global templates and forms (incl. study plans)
- Pre-populate study level documents, forms and templates
- Write, control and distribute meeting minutes during GSSU (study) meetings
- Assist study teams in submission preparation
- Assist in set-up of start-up tracking systems in CTMS
- Assist in tracking relevant information and data in CTMS and/or other tracking tools
- Assist in (CTMS) report generation and review
- Check completeness of CTMS for all GSSU areas and follow-up with involved stakeholders where required.
- Initiate and control signature process of study specific GSSU documents
- Assist in document redaction for EU CTR submissions
- Assist other Study Start-Up team members with filing documents in (e)TMF for which they are document owner
- Assist in transferring changes from Study Master site contracts into country
- and/or site specific site contracts and assist in arranging translations as applicable

**Management,** Learning &** Development **-** Actively support to staff learning & development within the company

**Quality Management **-** Draft and contribute as Subject Matter Expert (SME) in the field of GSSU activities to the evaluation/improvement of processes and procedures within the Quality Management System

**Account Management,** Sales & Acquisition **-** Contribute to good communication and relationships with (future) clients

**Requirements**:

- Life science, healthcare, biological science and/or business degree; or equivalent combination of education, training, and experience
- Previous experience in drug development and/or clinical research preferred
- Basic knowledge of GxP, GDPR, and applicable (local) regulatory requirements
- Good written and verbal communication skills including good command of English language
- Representative, outgoing and client focused
- Ability to work in a fast-paced challenging environment of a growing company

**Benefits**
- Comprehensive benefits package
- Competitive salaries per location
- Departmental Study/Training Budget for furthering professional development
- Flexible Working hours (within reason)
- Internal growth opportunities and career progression
- More task variety
- Financially rewarding internal employee referral program
- Access to online soft-skills and technical training via GoodHabitz and internal platforms

LI-JC1

  • Study Start-up Cra

    hace 1 mes

    Madrid, España Novartis A tiempo completo

    The Study Start-Up CRA is accountable for site selections as well as study-specific start-up activities and deliverables of assigned sites for Phase I-IV GDD trials within the country in adherence with monitoring procedures and processes in accordance with ICH/GCP, local regulations and SOPs. Proactive site preparation and early identification of real site...

  • Study Start-up Clinical Research Associate

    hace 4 semanas

    Madrid, España Novartis A tiempo completo

    395138BR **Study Start-Up Clinical Research Associate (Remote)**: Spain **About the role** **Location**:This is a remote, field based role with an average number of 2/3 site visits per week across Spain. As our **Study Start-Up CRA** your role has a high impact for Novartis. This exciting role covers everything from early identification of real site needs...

  • Project Manager Start Up

    hace 4 semanas

    Madrid, España Labcorp A tiempo completo

    **Project Manager Start Up, EMEA, Remote** Helping our clients make their clinical trials a success by orchestrating the efforts of top-talented Clinical Research Teams. As **Project Manager Start Up** your principal responsibility is to oversee and manage the start-up through maintenance phase of domestic and/or international clinical trials. This...

  • Senior Study Start-up Lead

    hace 1 mes

    Madrid, España Caidya A tiempo completo

    **Job Title: Senior Study Start-Up Lead (SSUL)** **Job Location**: Madrid, Spain**Job Overview**: Job Duties and Responsibilities: - Act as a SSU lead for the assigned countries and regions, participating directly at kick-off meetings, sponsor calls, providing the client with procedural and legal guidance, and study updates and advice as how to respond to...

  • Associate Study Start-up Manager

    hace 4 semanas

    Madrid, España Novasyte A tiempo completo

    Associate Study Start-Up Manager IQVIA Biotech Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources. Essential Functions: - Oversee the execution of Site Activation...

  • Senior Study Start-Up Lead

    hace 4 semanas

    Madrid, España Caidya A tiempo completo

    Job Overview: The Senior Study Start-Up Lead (Sr. SSUL) will be involved in managing global and/or regional submission of global applications for clinical trials for studies executed by the Company on behalf of clients. The Sr.SSUL should be able to independently compile, review and approve CORE essential study documents and have solid understanding...

  • Regulatory and Start Up Manager

    hace 1 día

    Madrid, Madrid, España IQVIA A tiempo completo

    Job OverviewDirect and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources. Fluent in Spanish and English.Essential Functions Oversee the execution of Site Activation (including...

  • Local Study Associate Director

    hace 4 semanas

    Madrid, España AstraZeneca A tiempo completo

    At AstraZeneca we believe in the potential of our people and you’ll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us. To lead Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according...

  • Regulatory and Start Up Manager

    hace 3 días

    Madrid, España IQVIA A tiempo completo

    Job Overview Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources. Fluent in Spanish and English. Essential Functions Oversee the execution of Site Activation...

  • Clinical Research Coordinator

    hace 3 días

    Madrid, España IQVIA A tiempo completo

    Are you looking for an opportunity in Clinical Research? Do you want to work for an industry leading company. If so, come and join us - IQVIA are looking for a Clinical Research Coordinator/ Study Nurse. This part-time (24 hours) role, is planned for 11 months and is to support the site in Sanlucar der Barrameda in conducting a clinical trial in the field...

  • Study Tour Manager

    hace 1 mes

    Madrid, España AIL Madrid A tiempo completo

    with the ability to show initiative and learn quickly. - Cultural adeptness and capacity to work with staff and clients of diverse ethnicities, cultures and languages. Qualifications and experience required to undertake role - Qualifications: - Master ́s degree. - International work and /or study experience. Other: - Available to travel internationally...

  • Social Media Intern

    hace 1 mes

    Madrid, España Cüimo A tiempo completo

    ¿Eres un/a apasionado del Instagram y de las motos? ¡Cüimo es tu lugar! Somos una start-up jóven y dinámica, asentada en Madrid, que está revolucionando la forma de comprar y vender motos en España. Estamos buscando una persona con gran motivación para hacer cosas chulas en nuestra cuenta de Instagram, ofreciendo el mejor contenido para nuestro...

  • Ingeniero/A Desarrollador/A Senior Web

    hace 7 días

    Madrid, España Start People A tiempo completo

    START PEOPLE selecciona un Ingeniero/a Desarrollador/a Senior Aplicaciones Web con experiencia de al menos 5 años en programación full stack con tecnología .Net Core y Angular para formar parte del equipo interno de nuestro cliente y colaborar en proyectos relacionados con plataformas de servicios y flujos de trabajo internos. Ubicación Madrid (Las...

  • Operations intern

    hace 1 mes

    Madrid, España Cuimo A tiempo completo

    Funciones y responsabilidades 💻 ✍🏽En Cüimo, ayudarás al equipo de operaciones en todo el proceso de venta de una moto, desde que se reserva hasta que se entrega al cliente. 💻Para ello, tendrás un trato directo con todos los proveedores de Cüimo (mecánicos, gestoría, transportistas, financieras, aseguradoras...). Además, tendrás asignadas...

  • Ingeniero/a Desarrollador/a Senior .NET Angular

    hace 6 días

    Madrid, España Start People A tiempo completo

    START PEOPLE selecciona un Ingeniero/a Desarrollador/a Senior Aplicaciones Web con experiencia de al menos 5 años en programación full stack con tecnología .Net Core y Angular para formar parte del equipo interno de nuestro cliente y colaborar en proyectos relacionados con plataformas de servicios y flujos de trabajo internos. * Ubicación Madrid (Las...

  • Social Media Intern

    hace 1 mes

    Madrid, España Cüimo A tiempo completo

    ¿Eres un/a apasionado del Instagram y de las motos? ¡Cüimo es tu lugar! Somos una start-up jóven y dinámica, asentada en Madrid, que está revolucionando la forma de comprar y vender motos en España. Estamos buscando una persona con gran motivación para hacer cosas chulas en nuestra cuenta de Instagram, ofreciendo el mejor contenido para nuestro...

  • Ingeniero/a Desarrollador/a Senior .NET Angular, hibrido

    hace 7 días

    Madrid, España Start People A tiempo completo

    Ingeniero/a Desarrollador/a Senior .NET Angular en hibrido.START PEOPLE selecciona un Ingeniero/a Desarrollador/a Senior Aplicaciones Web con experiencia de al menos 5 años en programación full stack con tecnología .Net Core y Angular para formar parte del equipo interno de nuestro cliente y colaborar en proyectos relacionados con plataformas de servicios...

  • Operations intern

    hace 1 mes

    Madrid, Madrid, España Cuimo A tiempo completo

    Funciones y responsabilidades En Cüimo, ayudarás al equipo de operaciones en todo el proceso de venta de una moto, desde que se reserva hasta que se entrega al cliente.Para ello, tendrás un trato directo con todos los proveedores de Cüimo (mecánicos, gestoría, transportistas, financieras, aseguradoras...). Además, tendrás asignadas conversaciones...

  • Summer Intern

    hace 4 semanas

    Centro-Madrid, España World Abroad Connect A tiempo completo

    **Company Description**: World Abroad Connect is an educational organization specializing in coordinating study abroad programs for American students in vibrant European cities, including Milan and Madrid. We offer unique opportunities for international learning, allowing participants to immerse themselves in diverse cultures and enrich their academic and...

  • Social Media Intern

    hace 1 mes

    Madrid, Madrid, España Cüimo A tiempo completo

    ¿Eres un/a apasionado del Instagram y de las motos? Cüimo es tu lugarSomos una start-up jóven y dinámica, asentada en Madrid, que está revolucionando la forma de comprar y vender motos en España.Estamos buscando una persona con gran motivación para hacer cosas chulas en nuestra cuenta de Instagram, ofreciendo el mejor contenido para nuestro público...