Clinical Document Specialist

Há 2 dias

São Luís, Maranhão, Brasil beBeeDocument Tempo inteiro US$86.000 - US$95.000

**TMF Specialist Position Overview**

This role is a fantastic opportunity to contribute to the success of our clinical trial operations by ensuring the accuracy and compliance of trial documents in our electronic Trial Master File (eTMF) system.

We are looking for an organized and detail-oriented individual who can review and quality check trial documents, file and maintain essential records, and support filing and archiving across multiple clinical studies.

Responsibilities:
  • Conduct thorough reviews of trial documents to ensure accuracy and compliance with regulatory guidelines.
  • Maintain accurate and up-to-date records in the eTMF system, including flagging and tracking quality issues.
  • Collaborate with cross-functional teams to ensure seamless filing and archiving processes.
  • Support the development and implementation of efficient filing processes and guidelines.

In this role, you will have the opportunity to work closely with our team to develop and implement process improvements, ensuring that our trial documents meet the highest standards of quality and compliance.

Required Skills and Qualifications:
  • Bachelor's degree or equivalent.
  • 2-4 years of experience in clinical trials, TMF, or related roles (Sponsor, CRO, or Site).
  • Knowledge of ICH-GCP, good documentation practices, and eTMF systems (e.g., Veeva).
  • Excellent communication and organizational skills.
Benefits:
  • Competitive annualized base salary range: $86,000-$95,000 USD.
  • World-class benefits package, including medical, dental, and vision plans.
  • Company-paid life insurance, AD&D, disability benefits, and voluntary plans.
  • Flexible wellness benefit and generous PTO policy.
Diversity, Equity & Inclusion:

We are committed to creating a workplace where everyone feels valued, respected, and supported. We strive to advance diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day.

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