Technical Documentation Specialist II
7 days ago
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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