TMF Study Lead
Company: Bristol-Myers Squibb AgileOne
Posted on: July 29, 2020
TMF Study Lead
needed for a 12-month
with Yoh Scientific's client located in
Lawrenceville, NJ. 5 years of TMF experience is required!
Max pay rate $42/hr
TMF Study Lead for Closed-Out and Archival Studies
Functional Area Description The centralized TMF organization is
responsible for the completeness and accuracy of the Trial Master
File for all
studies. The group will deliver technical expertise in the Trial
Master File (paper TMF & electronic TMF) management and will
provide support for the book of work for all
clinical trials throughout the lifecycle of the trial. The group
will support inspection readiness goals in compliance with ICH/GCP
Guidelines, regulatory requirements and internal policies.
Position Summary / Objective
Key deliverables include monitoring and assessing the overall
health of the TMF, ensuring quality, completeness and timeliness in
the eTMF for all
studies, working with the study teams and Clinical Trial
Subject Matter Expert for TMF/eTMF, spans across all therapeutic
areas and research phases, collaborates with cross-functional
teams, TMF Contributors, TMF Content Owner, eTMF Business
Operations and CRO/third party vendor during the close-out and
archival cycle of the trials.
--- Monitor the adherence to ICH/GCP Guidelines, regulatory
requirements and BMS policies as it relates to the completeness and
accuracy of the TMF at the study level by ensuring the required
documents reside in the TMF as per the Study-Specific Master Plan
and Master List and are inspection ready at all times.
--- At study completion, ensure the TMF is ready to be
--- Coordinate the long-term storage archival of original documents
and maintain document integrity per retention policies.
--- Ensure all expected documents are complete and final in eTMF in
collaboration with TMF Content Owner and Study team (study team
serve as SME for their respective departments).
--- Work proactively and prospectively with TMF Content Owner and
TMF Contributors at Study, Country and Site level to ensure timely
reconciliation and archiving of all Essential Documents in the
--- Ensure controlled access to eTMF Archive and other TMF-related
archive systems, as applicable.
--- Ensure systems owners take any necessary actions aimed to
protect from unauthorized changes, as relevant to the specific TMF
--- Ensure the study documentation received by third party is
complete, includes a documentation inventory list, and meet quality
criteria before archiving documents.
--- For documents transferred from the CRO, ensure transfer to
appropriate long-term archive location.
--- Periodically perform risk-based quality reviews of the TMF
content by utilizing metrics and reports to assess any missing
documents and then following-up with the appropriate functional
group or document owner to mitigate, as per established review
--- Generate, organize, and deliver on TMF performance metrics at
the site, study, country and compound levels.
--- Provide support to TMF implementation, internal audits and
Degree Requirements:Minimum of Bachelor's degree in a scientific or
At least 5 years of TMF experience required, including experience
in study start-up, maintenance and closeout, and performing quality
and completeness reviews.
Relevant experience in clinical trials related roles (i.e. clinical
operations and project management). Previous experience with
independently managing projects and handling concurrent tasks in a
fast-paced environment and delivering results within tight
timelines is desirable.
Contact: Nicole.Richman@yoh.com or text 267-323-4968!
What's In It For You?
We welcome you to be a part of one of the largest global staffing
companies to meet your career aspirations. Yoh's network of client
companies has been employing professionals like you for over 65
years in the U.S., UK and Canada. Join Yoh's extensive talent
community that will provide you with access to Yoh's vast network
of opportunities and gain access to this exclusive opportunity
available to you.
Medical, Dental & Vision Benefits
401K Retirement Saving Plan
Life & Disability Insurance
Direct Deposit & weekly ePayroll
Employee Discount Programs
Referral Bonus Programs
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and UK. Find out more
Yoh, a Day & Zimmermann company, is an Equal Opportunity
to contact us if you are an individual with a disability and
require accommodation in the application process.
#ZipESD Yoh Staffing.Category: Science, Keywords: Clinical Trial
Keywords: Bristol-Myers Squibb AgileOne, Levittown , TMF Study Lead, Other , Levittown, Pennsylvania
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