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TMF Study Lead

Company: Bristol-Myers Squibb AgileOne
Location: Levittown
Posted on: July 29, 2020

Job Description:

TMF Study Lead
needed for a 12-month
contract opportunity
with Yoh Scientific's client located in
Lawrenceville, NJ. 5 years of TMF experience is required!

Max pay rate $42/hr

Description:

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 Managers.
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.




Position Responsibilities

--- 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 archived.

--- 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 TMF.

--- 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 system.

--- 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 schedule.

--- Generate, organize, and deliver on TMF performance metrics at the site, study, country and compound levels.

--- Provide support to TMF implementation, internal audits and regulatory inspections.



Degree Requirements:Minimum of Bachelor's degree in a scientific or related discipline



Experience Requirements:


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



Yoh makes finding and applying for jobs simple. Partner with Yoh to find the right opportunities across multiple industries in the US and UK. Find out more
here!


Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer,
M/F/D/V.

Click here
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 Manager

Keywords: Bristol-Myers Squibb AgileOne, Levittown , TMF Study Lead, Other , Levittown, Pennsylvania

Click here to apply!

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