Associate Ii, Tmf Operations - Brazil - Remote

buscojobs Brasil; São Paulo; Teletrabalho; BRL 20.000 - 80.000; Tempo integral

Resumo da oferta

A leading company seeks an Associate II, TMF Operations to support the management and compliance of essential documents. The role involves processing TMF documents, ensuring quality control, and maintaining regulatory standards in a global setting. Ideal candidates possess strong skills in electronic document management and have a background in life sciences.

Qualificações

• 1-2 years of relevant experience in TMF operations.
• Experience in a regulated industry is desirable.

Responsabilidades

• Process and review Trial Master File documents for complex studies.
• Perform periodic TMF Quality Control to ensure adherence to standards.
• Manage document-related administrative support for quality checklists.

Conhecimentos

Proficiency in electronic document repository

Interpersonal skills

Judgment and decision-making

Proficiency in Microsoft Word

Proficiency in Microsoft Excel

Formação académica

University Degree (Life Science preferred)

Descrição da oferta de emprego

What the Associate II, TMF Operations does at Worldwide

The Associate II, TMF Operations is responsible for the processing, maintaining and archiving of all essential documents in compliance with the relevant Standard Operating Procedures, ALCOA principles, country regulations and industry best practice. The Associate will support the delivery of department objectives in ensuring the management essential documents. This is a global role and will require working with Worldwide Project Team members.

What you will do

• Process, review, and resolve rejected Trial Master File (TMF) documents, for complex studies or Sponsor portfolio of studies both in an electronic and hard copy format.
• Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices.
• Work with a variety of Electronic Document Management and electronic TMF Systems to review, classify and process Essential Documents.
• Communicate directly with RMC Lead to report trends and issues relevant to the TMF.
• Escalate any TMF Quality issues in a timely manner to RMC Lead.
• Provide administrative support for the RMC Lead including but not limited to filing and maintaining internal documents on study SharePoint (TMF Quality Control checklists and different trackers).

What you will bring to the role

• Proficiency in use of an electronic document repository or eTMF, and document recognition skills.
• Strong interpersonal skills in a fast-paced, deadline oriented, rapidly changing environment
• Sound judgment and ability to identify decisions requiring supervisory approval.
• Proficiency in Microsoft Word and Excel.

Your experience

• University Degree preferred (Life Science desirable)
• 1-2 years of relevant experience
• Knowledge of working within a highly regulated industry (desirable)