Clinical Documentation & Systems Specialist – Clinical R&D
| Company | Eikon Therapeutics |
|---|---|
| Location | San Bruno, CA, USA, New York, NY, USA |
| Salary | $113000 – $123500 |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PhD |
| Experience Level | Senior |
Requirements
- Typically requires a minimum of 5 years of related experience with a Bachelor’s degree; or 3 years and a Master’s degree; or a PhD without experience; or equivalent work experience.
- Experience managing electronic document management systems and document control processes preferred.
- Sound working knowledge of Good Clinical Practice (GCP).
- Demonstrated knowledge of Microsoft Office
- Excellent verbal and written communication skills.
- Team-oriented individual with the ability to effectively work within a team environment.
- Experience with Veeva
Responsibilities
- Maintain access control, versioning and lifecycle management of GxP procedural documents within the Document Management System
- Support the Quality Management System (QMS)
- Perform Document Control administrative tasks in the document management system, including processing change requests, routing documents for approval, and publishing approved documents
- Perform reviews to maintain quality standards in document formats and conformance to document templates
- Collaborate with document authors on the development of new documents
- Coordinate periodic review activities
- Maintain the Standard Operating Procedure Glossary
- Participate in system upgrades and or configuration changes as required
- Collaborate with functional area leaders to maintain the training matrix and curricula
- Create training requirements and assign required training to employees
- Create and manage course quizzes
- Manage training records, including collection and period review of CVs, job descriptors and training certificates
- Generate and distribute training compliance reports
- Participate in system upgrades and or configuration changes as required
- Support maintenance of organization and personnel data in Global Directory
- Ensure accurate and consistent global data collection and curation through adherence to internal data standards
- Generate clinical reports and perform quality checks of expected vs actual data entered
- Collaborate with study teams to resolve data queries
- Participate in system upgrades and or configuration changes as required
Preferred Qualifications
- Experience managing electronic document management systems and document control processes preferred.