Clinical Trial Assistant - Based in Spain

IQVIA; Madrid; Presencial; EUR 24.000 - 36.000; Jornada completa

Descripción de la vacante

IQVIA is seeking a Clinical Trials Assistant to support daily TMF activities, document control, and coordination with CRAs and RSU teams to keep study files complete and compliant.

You will help prepare, file, and archive clinical documents, assist with study file reviews, and handle CRF tracking and query resolution under project timelines.

Requirements include a life sciences degree, at least 1 year of CT assistant experience, and fluent English and Spanish.

Formación

• Bachelor's degree in life sciences or related field preferred.
• At least 1 year of experience as Clinical Trials Assistant.
• Strong written and verbal communication in English and Spanish.

Responsabilidades

• Assist CRAs and RSU with updating and maintaining TMF and documents.
• Prepare, handle, file and archive clinical documents and reports per SOPs.
• Conduct periodic reviews of study files for completeness.
• Support distribution of Clinical Trial Supplies and tracking information.
• Track Case Report Forms (CRFs), queries and data flow.

Conocimientos

Time management

Communication skills

Bilingual English/Spanish

Educación

Bachelor's degree in life sciences

Herramientas

Microsoft Word

Excel

PowerPoint

Descripción del empleo

Job Overview

Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.

Essential Functions

• Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.
• Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
• Assist with periodic review of study files for completeness.
• Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
• Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
• Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
• May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.

Qualifications

• Bachelor's or higher-level degree preferable in life science.
• At least 1 year of experience as Clinical Trials Assistant.
• Equivalent combination of education, training and experience.
• Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.
• Written and verbal communication skills - must be fluent in both English and Spanish.
• Effective time management and organizational skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• Awareness of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines as provided in company training.
• Knowledge of applicable protocol requirements as provided in company training.

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com .

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

At IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone, everywhere. When our talented employees bring their authentic selves and their diverse experiences to work, they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes. Likewise, as part of this culture, IQVIA is committed to ensuring effective equality between women and men, integrating it as a strategic principle in its corporate and human resources policies.