TMF Operations Senior Associate — Compliance Lead

Worldwide Clinical Trials; Municipio de Rincón de los Sauces; Presencial; ARS 68.019.000 - 113.365.000; Jornada completa

Descripción de la vacante

Worldwide Clinical Trials is seeking a TMF Records Management professional to support our global TMF Operations. You will oversee lead activities, ensure quality control, and collaborate with project teams and sponsors to maintain compliance.

Ideal candidates have a university degree, 1–3 years in a regulated CRO/pharma setting, and strong analytical and communication skills to navigate complex regulatory environments.

Formación

• Proficient understanding of clinical research principles, industry standards and regulations applicable to TMF Management
• Demonstrate strong planning and organizational skills with ability to work under pressure
• Display strong interpersonal skills in a fast-paced, deadline oriented, rapidly changing environment
• Possess excellent written and verbal communication skills to clearly and concisely present information to internal and external parties
• Ability to identify solutions and make decisions or have awareness to consult to find optimal regulatory compliant solutions including those required for complex technical situations.

Responsabilidades

• Perform RMC Lead Activities, managing a number of complex studies or Sponsor portfolio of studies.
• Communicate directly with multiple Project Team members and Sponsors to assess project needs relevant to the TMF and to provide Subject Matter Expertise (SME).
• Oversee the Quality Control process including planning, reporting and follow up on non-compliance accordingly.
• Assist in development of project specific TMF Quality Management Documents.
• Prepare, maintain, and present TMF Key Performance Indicators and underlying data analysis trends with Project Teams and Sponsors.
• Support Regulatory and Sponsor audits and audit finding resolution, where necessary.

Conocimientos

TMF management

Regulatory compliance

Planning & organization

Interpersonal skills

Written and verbal communication

Educación

University degree

Life science background

CRO/pharma experience

Descripción del empleo

Worldwide Clinical Trials is seeking a TMF Records Management professional to support our global TMF Operations. You will oversee lead activities, ensure quality control, and collaborate with project teams and sponsors to maintain compliance.

Ideal candidates have a university degree, 1–3 years in a regulated CRO/pharma setting, and strong analytical and communication skills to navigate complex regulatory environments.