Technical Documentation Specialist II

5 days ago


Fort Worth, United States Mindlance Full time
Benefits:
  • Coordinate collection and processes essential trial documents between investigator sites and Alcon 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


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