Clinical Document Management Specialist I

Posted Aug 16, 2019
Project ID: SHPGJP00004530
Cambridge , MA
6 months
(Aug 26, 2019 - Feb 28, 2020)
40 hrs/week
Payrate range
Education Requirements:

• Bachelor's degree
• Master’s level degree in Library Science, Archiving or Regulatory Affairs is a plus

Skill Requirements:

• Ability to manage competing and re-prioritizing tasks
• Excellent verbal and written communication
• Customer service experience is a plus
• Experience with SharePoint and Office 365 is preferred
• Experience with Oracle and SaaS-based systems is preferred
• Documentation, archive or laboratory science experience

Job Summary:

The R&D Scientific Documentation group is offering a 6-month contract to a detailed oriented candidate to assist the consolidation and management of study records (Good Laboratory Practices and Good Clinical Practices) to a third-party archive vendor.

Candidate will assist in the improvements of metadata of our offsite storage collection. Efforts will focus on the location, confirmation and input of metadata into the Oracle and SaaS systems.

Efforts will focus on chain of custody (provenance) documentation, inventory management data entry, record retention scheduling and dispositions, as well as research in inventory management system to support regulatory filings.

Daily activities should include:

• Data entry in both Oracle and SaaS system.
• Support transfer ownership activities related to materials either divested or acquired.
• Locating and index study information for NCD requests and submission.
• Supporting the logistics to centralize off site material to Shire preferred vendors.
Job Posting Number of Positions
Business Unit
Job Posting Service Type
Business Need
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