Specialist, Trial Master File
Company: Yoh, A Day & Zimmermann Company
Location: Allston
Posted on: April 11, 2021
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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
https://www.yoh.com/applicants-with-disabilities 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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