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Specialist, Trial Master File

Company: Yoh, A Day & Zimmermann Company
Location: Allston
Posted on: April 11, 2021

Job Description:

The TMF Specialist is responsible for supporting a high quality TMF, performing quality checks, archival and retrieval of records for the Client Trial Master Files (TMF). Responsibilities include but are not limited to driving and overseeing successful completion of all TMF deliverables such as TMF Business Administration tasks, TMF Plan development, TMF set-up and QC review activities, and archiving.
Summary of Key Responsibilities
eTMF Administration
------- May act as eTMF Business Administrator for user account management, create and promote studies in the eTMF, and unblinding
------- Manage askTMF mailbox and maintenance of an FAQ log
------- Support Study EDLs and Milestones configuration and management
TMF Quality
------- Create and manage Study TMF Filing plan with input from Study team
------- Support TMF review process by working closely with study teams, CROs and Vendors
------- Preform assigned TMF review actions in a timely manner
------- Provide Study teams with relevant reports and outputs to support TMF Quality
------- Ensure Inspection Readiness review of TMF is completed and documented
------- Support study teams for resolution of TMF-related queries or quality issues
------- Support TMF audits and inspections as required
Paper TMF
------- Set-up TMF paper folders, as applicable
------- Manage TMF inventory trackers
------- Prepare for receipt of CRO--------s portion of the TMF
------- Process the CRO--------s portion of the TMF in a timely and controlled manner
------- Manage, track and document TMF records received, filed, archived, retrieved, transferred and destroyed in compliance with company policies
TMF Archiving
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit to contact us if you are an individual with a disability and require accommodation in the application process.PandoLogic. Keywords: TMF Specialist, Location: Allston, MA - 02134

Keywords: Yoh, A Day & Zimmermann Company, Boston , Specialist, Trial Master File, Other , Allston, Massachusetts

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