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Documents Specialist II

1 hour, 16 minutes ago
India
Full-time
Senior
Technical Writer
Technical Writing and Documentation
Apply Now
Precision Medicine Group

Precision Medicine Group

Precision Medicine Group specializes in precision medicine, utilizing targeted expertise and data insights to accelerate drug development and enhance the commercialization of next-generation medical products for the pharmaceutical and life sciences ind...

Pharmaceuticals
251-1K
Founded 2012
View All Jobs 145

Description

  • Prepare TMF plans in accordance with applicable clinical trial and regulatory requirements.
  • Perform document quality control and indexing within the eTMF for assigned studies.
  • Monitor document submission and processing timelines to prevent backlogs and escalate issues when needed.
  • Distribute TMF metrics and follow up on document clarifications until they are resolved.
  • Manage close-out activities for assigned studies, including final document submission and document wrap-up.
  • Request the eTMF export and coordinate transfer of the eTMF to the client.
  • Obtain and track acknowledgement of receipt for transferred study documentation.
  • Maintain compliance with GCP, ICH E6, relevant regulations, and Precision SOPs.

Requirements

  • 4-year college degree or equivalent combination of education and experience, ideally in a business, scientific, or healthcare discipline.
  • Minimum 5 years of clinical trial experience.
  • Minimum 3 years of experience with TMF and/or eTMF.
  • Established experience and fluency with Microsoft Office applications, including Outlook, Word, Excel, and PowerPoint.
  • Ability to speak English proficiently at a professional level.
  • Working knowledge of ICH-GCP, relevant Precision SOPs, and regulatory guidance, or the ability to be trained and retain this knowledge.
  • Strong interpersonal skills and the ability to work independently as well as in a team environment.
  • Detail-oriented, self-motivated, and able to plan work independently.
  • Professional communication skills, both verbal and written.
  • Positive, professional conduct with internal and external stakeholders.

Interested in this position?

Apply directly on the company website

Apply Now

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