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TMF Specialist

Actalent

09/15/2021

Posting ID: JP-002332061

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Durham, North Carolina
Full Time
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Description:

Must Haves: 3 years experience TMF Trial management - Need to be able to speak up during study team meetings (vocal and will speak up and discuss issues with their studies) Collaborates with the clinical study team to set up, manage and oversee the study trial master file (TMF). Creates and maintains the TMF plan and the study specific inventory list. Advise the study team about the status of the TMF (completeness, quality and timeliness) and ensures the completion and resolution of the periodic quality reviews. Responsible for locking the TMF at the end of the study following approval by all functional areas. • Serve as the steward of the study eTMF to make sure the process to ensure completeness, quality and timeliness is followed by the study team. • Effectively communicate and drive document management compliance and quality issues to the clinical study teams and management. • Present eTMF at study Kick-off meeting and investigator meetings (CRA training) and attend regular study team meetings as applicable to report on the status of the TMF • Support the clinical study teams to ensure study TMFs are submission and inspection ready at all times. • Prepare the study specific TMF plan and corresponding study inventory list and insure they are current throughout the study and finalized at study completion. • Conduct documentation reviews of the TMF looking for areas missing significant documentation, logical checks (missing versions, missing documentation from 1572 participants, correct number of sites, etc), gross errors in location, inconsistencies in naming conventions. • Ensure QC reviews are conducted as prescribed in the TMF plan and that issues identified are addressed • Support the study team during inspections and audits as necessary. • Present eTMF at study Kick-off meeting and investigator meetings (CRA training) and attend regular study team meetings as applicable to report on the status of the TMF • Manage deletion/demotion requests throughout the duration of the study (Once TransperfecteTMF workflow is in place) • Answer any filing queries or general Transperfect eTMF questions from CRO/study team • Ensure Transpefect eTMF is set up for the study

Skills:

eTMF, TMF, Transperfect

Top Skills Details:

eTMF,TMF,Transperfect

Additional Skills & Qualifications:

3+ years eTMF exp Transperfect eTMF exp Minimum 2 Yr Degree

Experience Level:

Intermediate Level

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Contact Information

Recruiter: Jean Chambers

Phone: (410) 579-3072

Email: jchambers@careercircle.com

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