Highly Competitive Salary
  1. Contract
  2. Project/Study Manager (CSM/CPM)
  3. United States
Foster City, California
Posting date: 19 Jul 2019

Proclinical is currently seeking a Document Management Associate for a Biotechnology company located in Foster City, CA. Successful candidate will be a part of the Document Management Team (DMT) and will collaborate closely with Development Business Operations functional groups, Clinical Records, and Clinical Operations study teams in the planning, development, and implementation of standards, processes and projects to ensure DMT's effectiveness and efficient archival of clinical agreements and related information created in support of clinical research. This person will comply with relevant regulatory, legal, country specific and corporate requirements to produce and maintain inspection readiness for clinical records.

Job Responsibilities:

  • Collaborating with Development Business Operations functional groups, Clinical Operations study teams and functional areas outside of Development Business Operations to ensure compliance with policies, procedures, and the practices of company's records management/TMF archival initiative.
  • Working with management and DMT personnel in the development, implementation and maintenance of classification and filing systems to meet administrative, research, regulatory, legal, and financial requirements.
  • Working with management to manage business continuity procedures, including management of paper agreements.
  • Evaluating regulatory and company business recordkeeping, archiving requirements, and organizational objectives and ensure Development Business Operations DMT is aligned with all.
  • Responsible for continuing maintenance of eTMF (GDAR) and Apttus contract filing.
  • Support the integration and implementation of eTMF contract archival in Veeva.
  • Filing incoming documents and retrieving copy of paper protocol agreements from TMF room for Apttus filing.
  • Ensuring record filing is kept up to date is performed accurately by DMT members.
  • Developing and maintaining department process guidance, training materials, policies and procedures, and other quality documents
  • Defining and managing processes associated with the storing, archiving, indexing, scanning, and classifying clinical records.
  • Managing the off-site storage of records for Development Business Operations agreements and collaborating closely with company Clinical Records team to ensure the proper process is in place for off-site archival of paper agreements.
  • Responding to internal and/or external information inquiries related to contract filing and records retention of those agreements; supporting internal and external audits and inspections, including provision of data on contract filing.
  • Participating in the development, implementation and maintenance of internal systems and processes used to manage collections of agreements and filing of documents to GDAR and Apttus.

Skills and Requirements:

  • BA/BS required.
  • Microsoft Suite experience required.
  • Current knowledge and understanding of GCP, ICH and GLP regulations associated with the maintenance and retention of clinical agreements.
  • Prior experience with eTMF, VeevaVault is required.
  • Personable and able to learn new tasks quickly.
  • Excellent time management, organization, and effective communication skills.
  • Project Management skills and tools experience highly desirable.

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 Sherron Howard at (+1) 267-435-8600 or upload your resume on our website -

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.