Global CTA

IQVIA; Ciudad de México; Presencial; MXN 371,000 - 558,000; Jornada completa

Descripción de la vacante

A leading global clinical research firm in Mexico City seeks an Administrative Support professional to manage clinical documentation and assist research teams. Candidates should have a Bachelor’s Degree in Life Science or Health Care, along with administrative experience in clinical research. Strong communication and organizational skills are essential for success in this role.

Formación

• 3 years administrative support experience or intern experience in clinical research or pharma.
• Good command of English language, both written and verbal.
• Awareness of GCP and ICH guidelines.

Responsabilidades

• Assist CRAs and RSU with updating and maintaining clinical documents.
• Review study files periodically for completeness.
• Act as a central contact for project communications.

Conocimientos

Communication skills

Computer skills

Time management

Organizational skills

Educación

Bachelor Degree in Life Science or Health Care

Herramientas

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Descripción del empleo

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.
• 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 Degree in Life Science or Health Care.
• 3 years administrative support experience or an Intern experience in clinical research or pharma.
• Written and verbal communication skills including good command of English language.
• Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.
• 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