QA Document Specialist

Highly Competitive
  1. Contract
  2. Good Clinical Practice (GCP)
  3. United States
San Francisco, California
Posting date: 29 Jan 2019
QA.AS.21437_1548776460

A new job opportunity has arisen for a QA Document Specialist position to join a leading biopharmaceutical organisation with a solid history of research and developing life-saving drugs. ProClinical is advertising this position for an enthusiastic and hard-working individual to join this exciting company's office based in San Francisco.

The QA will provide contract administration support in response to Contracts Records Management and Cleanup for GDAR, Apollo migration, and Apttus CLMs. This is a contract role.

Job Responsibilities:

  • Taking responsibility for clinical administrative operations activities, including clinical contract and budget support.
  • Creating and maintaining study specific file structures for Gilead TMF documentation, and filing documents accordingly.
  • Creating file folders/labels according to TMF plan, file incoming documents, retrieving documents, and scheduling document reviews.
  • Ensuring record filing is kept up to date and is performed accurately.
  • Archiving documents offsite, and ensuring appropriate documentation is completed to track archival.
  • Converting paper documents to electronic records.
  • Participating in continued security and maintenance of the Trial Master Film (TMF) Room.
  • Completing responsibilities in a timely, organised way.
  • Identifying issues/problems and providing customary recommendations for solutions.
  • Reconciling contracts in Apollo and Apttus CLM.
  • Reviewing all executed clinical contracts saved on Apollo and Apptus CLM and performing reconciliation between the contracts that are saved in these two platforms.
  • Scanning and creating Optical Character Recognition (OCR) via Adobe Acrobat for various executed contracts, including CTAS, CDAs, LOAs, and Vendor Agreements.
  • Performing QA on the scanned contracts.
  • Entering Agreement Party Information on Apttus CLM.
  • Identifying metadata for each contract.
  • Uploading contracts to Apttus.
  • Completing required metadata fields in Apttus with contract party information.
  • Sending the physical copies of contracts, with RIM cover pages, to the Records Management Coordinator.

Skills and Requirements:

  • A BA or BS in a relevant discipline.
  • At least 2 years of experience, including experience in document management.
  • Demonstrable proficiency with CMS tools, such as TMF.
  • Proficiency in Microsoft Office Suite, particularly Excel.
  • Able to work independently and in a team.
  • Confidence, self-reliance, and quick learning skills all desirable attributes.
  • Good oral and written English communication skills.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Allison Stevens on +1215 531 5299 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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