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Clinical Document Management Specialist I
Ref No.: 18-12918
Location: Cambridge, Massachusetts
Position Type:Clinical
Start Date / End Date: 08/21/2018 to 02/20/2019

Job Description:

Location: Cambridge, MA
Type: 6 + Month Contract
Hours: 40 hours/week

Education Requirements:
  • Bachelor's degree
  • Masters in Library Science or Data Archiving, preferred
  • 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 financial systems is preferred
  • Documentation, archive or laboratory science experience

Summary:

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

Interacting with third vendors (Contract Research Organizations (CRO)) to confirm study information,
including:
  • Guide the detailing of record disposition centralize archive or discard
  • Locating and index study information for NCD requests and submission
  • Supporting the logistics to centralize off site material to client preferred vendors
  • Data entry in the Preclinical Information Management system (PIMS) to: updating and clean
  • up for legacy study information and archive location, updating vendor relationships and
  • information

Job Description
  • Support the Growing Archive Collection at EPL archive
  • Manage the logistics for Research and Nonclinical Operations in the long term archiving
  • of samples
  • Route POs, invoices, and vendor information in SAP, as well as recommend costeffective
  • improvement strategies
  • Maintain contracts and relationships with vendors and third parties
Logistical Archive Activities
  • Support the consolidation off-site storage account for GxP off site storage
  • Managing scanning effort for the Legacy Vienna Archive
  • Transfer for CRO data and records to/from any purchasing company
  • Ensuring required metadata is established from the seller
  • Updating metadata: adding records into systems (repositories, inventories, off-site
  • storage account, etc.)
  • Support the provenance chain custody and transfer of documents
  • Updating metadata for PIMS: removing records from systems regardless of media type;
  • updating metadata files;

Compliance
  • Administering archiving best practices to aid in regulatory submission (e.g. JNDA)
  • Subject Matter Expert (SME) for tracking and recording of archive shipments, storage
  • and destruction in the Preclinical Information Management system (PIMS)
  • Ensure processes adhere GLP/GCP regulations and client policies
  • Establish standard process documents including, SOP, BBP, WI and Policies as needed
Apply on-line for immediate consideration, please send your updated resume and contact info via
Contact: Asha Krishna
Email: asha@sunrisesys.com | 732-395-4591