Associate II, TMF Operations - Brazil - Remote

Worldwide Clinical Trials; Manaus; Teletrabalho; BRL 20.000 - 80.000; Tempo integral

Resumo da oferta

Worldwide Clinical Trials is seeking an Associate II, TMF Operations for a remote position in Brazil. The role involves processing and managing essential TMF documents, ensuring compliance with industry standards, and providing support to project teams. Ideal candidates will have a relevant university degree and 1-2 years of experience, as well as proficiency in document management systems and strong interpersonal skills.

Qualificações

• 1-2 years of relevant experience in a similar role.
• Knowledge of working within a highly regulated industry.
• University degree preferred.

Responsabilidades

• Process, review, and resolve rejected TMF documents for complex studies.
• Perform periodic TMF Quality Control to ensure adherence to standards.
• Provide administrative support for the RMC Lead.

Conhecimentos

Document recognition skills

Strong interpersonal skills

Sound judgment

Formação académica

University Degree (Life Science desirable)

Ferramentas

Microsoft Word

Microsoft Excel

Electronic document repository/eTMF systems

Descrição da oferta de emprego

Associate II, TMF Operations - Brazil - Remote

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)