Clinical Trial Assistant - Sponsor Dedicated - Lisbon

IQVIA; Oeiras; Presencial; EUR 25 000 - 35 000; Tempo integral

Resumo da oferta

A leading global clinical research provider is seeking an Administrative Support professional to assist Clinical Research Associates and Regulatory teams in maintaining clinical documentation. Ideal candidates will hold a High School Diploma, have 3-4 years of administrative experience, and possess strong communication skills. This role focuses on ensuring compliance and performance within project timelines, making effective organizational skills essential.

Qualificações

• 3-4 years administrative support experience.
• Minimum one year clinical research experience strongly preferred.
• Basic knowledge of applicable clinical research regulatory requirements.

Responsabilidades

• Assist with updating and maintaining clinical documents.
• Prepare, handle, and archive clinical documentation.
• Coordinate tracking and management of Case Report Forms.

Conhecimentos

Administrative support

Effective time management

Communication skills

Microsoft Office proficiency

Knowledge of clinical research regulations

Formação académica

High School Diploma or equivalent

Descrição da oferta de emprego

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. Coordinate 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.
• May collaborate with the clinical team on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.

Qualifications

• High School Diploma or equivalent Req
• 3-4 years administrative support experience.
• Equivalent combination of education, training and experience.
• Minimum one year clinical research experience strongly preferred.
• Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.
• Written and verbal communication skills including good command of English language.
• Effective time management and organizational skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• Basic knowledge of applicable clinical research regulatory requirement, 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.

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.