Technical Documentation Specialist II

7 days ago


Fort Worth, United States Randstad Life Sciences US Full time

A global company, we work in over 70 countries and serve patients in more than 140 countries. We have a long history of industry firsts, and each year we commit a substantial amount in Research and Development to meet customer needs and patient demands. Our leadership is grounded in cutting-edge innovation and breakthrough technology, transforming the way we treat eye diseases and eye conditions.

Job Description:

  • Coordinate collection and processes essential trial documents between investigator sites and Company CRD, including preparation and/or facilitating IRB/IEC submissions.
  • Ensure accuracy and quality of site documents included in the site initiation packets and throughout the duration of the study.
  • Enter and maintain site information and document tracking in current clinical trial management systems.
  • Ensure trial documentation is well organized, available, current, and archived in a timely manner in the sponsor Trial Master File and ensure audit readiness.
  • Follow applicable work processes, SOPs, communication plans, etc.
  • Ensure timely elevation of issues with sites related to preparation/collection of trial documents, initiation packets, site budget and contracts, or other relevant documentation.
  • May interact with and advise other functions on CTDM responsibilities. Interactions include but are not limited to Global Clinical Site Development, Clinical Trial Lead, Clinical Site Managers, etc.
  • May provide support before and during audits, both internal and external when applicable.

Preferred Qualifications:

  • Bachelor's degree in life sciences (Medical, pharmaceutical, biology, chemistry degree or RN)
  • 2 years related experience (e.g., business administration)
  • 1 year clinical trial experience (e.g., ophthalmology, study coordinator, etc.)
  • Proficient in Microsoft Office to include Word, Excel, PowerPoint
  • Excellent verbal and written communication skills
  • Excellent organization skills with exceptional attention to detail
  • History of working with multiple internal and external customers
  • Self-starter
  • Customer Focus
  • Action Oriented
  • Communicates Effectively
  • Collaborates



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