Clinical Document Management Specialist I

Katalyst Healthcares & Life Sciences - Cambridge, MA (30+ days ago)


Responsibilities:
80% Working member of an audit inspection-ready R&D paper and electronic Archives, responsibilities include:

Insure the timely return/closure of records from authors.
Manage the recall of archived records for legal and regulatory support.
Support the integration of records acquired via mergers and acquisitions.
monitor team inbox regularly for questions and requests on records.
Help to transition the use of Service Now, OpenLabs and SharePoint request management which includes, but is not limited to:
Support Training for new systems use and create quick use guides.
Trouble shooting request in for users in new system.
Support document Issuance: Issuing records to users in a timely manner including Reports, Protocols, Paper Notebooks, Databooks, Binders, etc.

20% Additional Administrative Responsibilities:
Revising, writing, reviewing and initiating new SOPs as needed.
Maintain contracts and relationships with vendors and third parties.
Route POs, invoices, and vendor information in SAP, as well as recommend cost-effective improvement strategies.
Conduct quarterly electronic laboratory and paper notebook training.

Requirements:
BS or BA required (or higher)
Experience as an archivist or documentation specialist, preferably in a biotech, pharmaceutical, or healthcare environment, with 1 years of experience BS or a BA, or pursuing of experience with MS or MA
Must be able to lift 15-30lbs on a routine basis.
Must also be able to use a stepladder to access physical records.
Experience working at a CRO, or in a Lab Science is a plus
CRM certification or MSLS/MSLIS is desirable
Experience with SharePoint, and Inventory/Content management systems such as (OmniRIM, FileBridge, etc.) preferred.