Clinical Trials Support Specialist: TMF & Study Docs

IQVIA; Barcelona; Presencial; EUR 26.000 - 36.000; Jornada completa

Descripción de la vacante

IQVIA in Barcelona, Spain, seeks a Clinical Trials Assistant to support daily administrative activities in collaboration with CRAs and RSU teams, ensuring accurate TMF delivery.

You will help prepare, handle and archive clinical documents, assist with study file reviews, and manage regulatory paperwork, with English and Spanish fluency required.

Join IQVIA to contribute to compliant trial operations and improved patient outcomes through effective collaboration and meticulous document control.

Formación

• 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 - 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., GCP and ICH guidelines.
• Knowledge of applicable protocol requirements as provided in company training.

Responsabilidades

• Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) teams with updating and maintaining clinical documents and TMF to track site compliance and performance within project timelines.
• Assist with preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to scope of work and SOPs.
• Assist with periodic review of study files for completeness.
• Assist with tracking and distribution of Clinical Trial Supplies and maintenance of tracking information.
• Assist with 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 and documentation.
• May accompany CRAs on site visits to assist with clinical monitoring duties after training.

Conocimientos

MS Word

Excel

PowerPoint

English & Spanish fluency

Educación

Bachelor’s or higher-level life sciences

Descripción del empleo

IQVIA in Barcelona, Spain, seeks a Clinical Trials Assistant to support daily administrative activities in collaboration with CRAs and RSU teams, ensuring accurate TMF delivery.

You will help prepare, handle and archive clinical documents, assist with study file reviews, and manage regulatory paperwork, with English and Spanish fluency required.

Join IQVIA to contribute to compliant trial operations and improved patient outcomes through effective collaboration and meticulous document control.