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TMF Manager

Allen Spolden

Auburn, Maine

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JOB DETAILS
SKILLS
Clinical Research, Clinical Trial, Clinical Trial Management, Communication Skills, Data Analysis, Data Quality, Detail Oriented, Documentation, FDA (Food and Drug Administration), Organizational Skills, Presentation/Verbal Skills, Regulations, Team Lead/Manager, Writing Skills
LOCATION
Auburn, Maine
POSTED
5 days ago
We are currently hiring full -time office based individuals for an exciting career in clinical research managing our Trial Master File. The Trial Master File (TMF) is a collection of documentation that allows the conduct of a clinical trial, and the integrity of the data produced to be evaluated by Regulatory bodies, such as the FDA. The TMF is an important tool, and can help teams manage trials more effectively and ultimately plays a big role in a new drug or device receiving approval by the FDA. In this position, you would be leading a highly experienced team of TMF professionals and working with members of trial teams to drive TMF strategy while ensuring our company TMFs are of high quality.<\/span>
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<\/span><\/div>Responsibilities :<\/span><\/b>
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The TMF Manager supports TMF oversight by providing strategic guidance and support regarding TMF processes to our company trial teams and sponsors. They ensure consistency across studies/programs, and participate in audits and regulatory inspections.<\/span>
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  • Ensure consistency of TMF across projects and clients;<\/span>
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  • Present on TMF process to clients, auditors, and inspectors; and,<\/span>
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  • Lead and develop team of TMF Associates and Administrators.<\/span>
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    Requirements<\/h3>
    • Bachelor’s degree;<\/span>
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    • A minimum of 5 years of experience working within the TMF;<\/span>
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    • High attention to detail;<\/span>
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    • Excellent organizational skills<\/span>
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    • Strong written and verbal communication skills; and<\/span>
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    • Knowledge of MS Office.<\/span>
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      Benefits<\/h3>
      Dental, Medical, Vision and 401K<\/div><\/span>

About the Company

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Allen Spolden