TMF Quality & Compliance Associate

Visa Hunt; Argentina; Presencial; ARS 135.892.000 - 196.289.000; Jornada completa

Descripción de la vacante

Worldwide Clinical Trials is seeking a dedicated TMF Operations professional to lead lead activities across complex studies and sponsor portfolios. You will collaborate with Project Teams and Sponsors to ensure TMF quality and regulatory compliance, and support audits as needed.

The role requires strong planning, organizational, and communication skills, with experience in a highly regulated CRO/pharma environment. A university degree and 1–3 years of relevant experience are preferred.

Formación

• Familiarity with TMF and regulatory standards.
• Strong planning and organizational skills.
• Effective written and verbal communication.
• Ability to work under pressure in a regulated setting.

Responsabilidades

• Lead TMF-related activities for multiple studies or sponsor portfolios.
• Coordinate with Project Team members and Sponsors to assess TMF needs.
• Oversee QC processes including planning, reporting and non-compliance follow-up.
• Assist in developing TMF Quality Management documents for projects.
• Prepare, maintain and present TMF KPIs and trend analyses to teams and sponsors.
• Support audits and audit finding resolutions with Regulatory and Sponsor teams.

Conocimientos

Clinical research

Regulatory knowledge

Project coordination

Communication skills

Team collaboration

Educación

University degree (Life Science desirable)

Descripción del empleo

Worldwide Clinical Trials is seeking a dedicated TMF Operations professional to lead lead activities across complex studies and sponsor portfolios. You will collaborate with Project Teams and Sponsors to ensure TMF quality and regulatory compliance, and support audits as needed.

The role requires strong planning, organizational, and communication skills, with experience in a highly regulated CRO/pharma environment. A university degree and 1–3 years of relevant experience are preferred.