Technical Documentation Specialist II

Exciting Documentation Specialist development opportunity to work for a global leader dedicated to helping people see brilliantly. The largest device company in the world – with complementary businesses in Surgical and Vision Care.

Technical Documentation Specialist II

Fort Worth, TX (Onsite)

24 months

$35.00-$42.00

• Coordinate collection and processes essential trial documents between investigator sites and 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.
• Self-starter
• Customer Focus
• Action Oriented
• Communicates Effectively
• Collaborates
  
  

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
  
  

This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

INDBH