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Records Management Associate - Remote

Posted Yesterday
All others
Full Time
India

Overview

The Records Management Associate is responsible for maintaining both paper and electronic documents in compliance with regulatory and legal guidelines, ensuring the integrity of the electronic Trial Master File (eTMF).

In Short

  • Maintain electronic and paper documents for eTMF.
  • Ensure compliance with Good Clinical Practices.
  • Assist in the migration of paper documents to eTMF.
  • Perform quality checks on document attributes.
  • Maintain document security and storage.
  • Interact with personnel for archive management.
  • Demonstrate advanced computer skills.
  • Lead projects with minimal supervision.
  • Train others in records management.
  • Implement process improvements in the department.

Requirements

  • Bachelor's Degree in Life Sciences, Records Management, or Library Sciences.
  • Minimum 2 years of experience in records management.
  • Extensive knowledge of regulatory/clinical documents.
  • Familiarity with record retention requirements.
  • Experience with clinical electronic systems.
  • Understanding of ICH/GCP guidelines.
  • Proficient in Microsoft Office and Adobe Acrobat.
  • Excellent interpersonal skills.
  • Ability to work independently.
  • Ability to manage multiple projects simultaneously.

Benefits

  • Opportunity to work in a dynamic environment.
  • Engagement in meaningful work that contributes to patient care.
  • Collaboration with a dedicated team.
  • Professional growth and development opportunities.
  • Flexible work arrangements.

F.F.P

FTPHP Fortrea Philippines

Fortrea Development India Private Limited is a leading global contract research organization (CRO) dedicated to scientific rigor and clinical development excellence. With decades of experience, Fortrea offers a comprehensive range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas, operating in approximately 100 countries. The company is committed to transforming drug and device development for pharmaceutical, biotechnology, and medical device clients, while also focusing on improving health and lives globally. Fortrea fosters a collaborative and inclusive work environment, encouraging personal growth and innovation among its employees.

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