Description
I have a great Specialist Study Management position available. Our client, a large pharmaceutical company, is looking to immediately fill a Specialist Study Management role.Responsibilities include:
* 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 Harmonisation 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 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
Rate: $30-35/hour
Duration: 12 months
Location: Wilmington, DE
If you are interested in this opportunity please forward your CV so we can set up a time to discuss further details. Feel free to pass this opportunity along to anyone you may feel is a better fit.
To find out more about Real please visit www.realstaffing.com