Associate II, TMF Operations - Brazil - Remote

Worldwide Clinical Trials; Brasil; Teletrabalho; BRL 60.000 - 90.000; Tempo integral

Resumo da oferta

A leading company in research services is seeking an Associate II for TMF Operations, responsible for the management of essential documents ensuring compliance with regulatory practices. The role requires strong document management skills, ability to work in a fast-paced environment, and a preferred background in Life Sciences.

Qualificações

• Preferred university degree in a relevant field.
• 1-2 years of relevant experience.
• Experience in a highly regulated industry is a plus.

Responsabilidades

• Process, review, and resolve rejected TMF documents.
• Perform periodic TMF Quality Control.
• Communicate directly with RMC Lead regarding TMF issues.

Conhecimentos

Document recognition skills

Interpersonal skills

Judgment

Proficient in Microsoft Word

Proficient in Microsoft Excel

Formação académica

University Degree (Life Science desirable)

Ferramentas

eTMF

Descrição da oferta de emprego

Associate II, TMF Operations - Brazil - Remote

Associate II, TMF Operations - Brazil - Remote

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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)

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research

• Industries

  Research Services

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