Description
Responsibilities include:- Development and management of the Trial Master File (TMF) or electronic TMF
- Liaison with clinical teams, study sites and CRO to ensure that all clinical trial documentation is received, compiled for FDA submission, and meets all Quality standards
- Review and QC of all documentation
- Ensures that the TMF is audit ready
- Assist clinical team in creating SOP's
- Assist team with development of timelines
Education/Experience:
- BS degree, Life Sciences preferred
- 5-7 years drug development experience, with a minimum of 2-5 years of clinical document management experience
- Broad knowledge of document management processes and procedures, electronic documentation systems, data retrieval, and electronic file formats
- Hard copy files/electronic documentation and electronic TMF development
- Strong working knowledge of ICH/GCP Guidelines
- Working on or contributing to Trial start up activities
- Interaction with multi-functional groups
- Microsoft Office Suite, SharePoint, Visio, CTMS, Adobe Acrobat Professional, and Web-based document indexing and viewing applications
To find out more about Real Staffing please visit www.realstaffing.com