My name is Logan Histed and I represent The Fountain Group. We are a national staffing firm and are currently seeking a Clinical Trial Document Management Specialist for a prominent client of ours. This position is Wilmington, DE. Details for the position are as follows:
- Operational responsibility to set-up the local Trial Master File (eTMF) and Investigator Site File including tracking of documents. Maintain and close the local TMF (in electronic or paper form depending on study) ensuring International Conference of Guidelines for Good Clinical Practice (ICH/GCP) compliance and local requirements. Support the CRA in the maintenance and close out activities for the ISF
- Contribute to the production and maintenance of study documents, ensuring template and version compliance
- Create and/or import clinical-regulatory documents into the Global Electronic Library (GEL) according to the Global Document List (GDL) ensuring compliance with the AstraZeneca Authoring Guide for Regulatory Documents to support publishing in GEL
- Contribute to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards i.e. Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities (not for international studies)
- Set-up, populate and accurately maintain information in tracking and communication tools (e.g. IMPACT, SharePoint etc) and support others in the usage of these systems
If you are interested in hearing more about the position please respond to firstname.lastname@example.org with your resume attached or contact me at (813)384-8972.
Please forward this email to any friends or colleagues as we do offer a Referral Bonus for any candidate hired.
Logan Histed| Talent Acquisition Recruiter
Logan.histed@TheFountainGroup.com | (813)384-8972
The Fountain Group gives you access to more opportunities in your area of expertise and allows you to gain advice and skills training that will help you advance in your chosen career field
The Fountain GroupLooking for a new career, or a change from your current work environment? The Fountain Group gives you access to more opportunities in your area of expertise and allows you to gain advice and skills training that will help you advance in your chosen career field