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.
Responsibilities :
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.
Ensure consistency of TMF across projects and clients;
Present on TMF process to clients, auditors, and inspectors; and,
Lead and develop team of TMF Associates and Administrators.
Requirements
Bachelor’s degree;
A minimum of 5 years of experience working within the TMF;
High attention to detail;
Excellent organizational skills
Strong written and verbal communication skills; and
Knowledge of MS Office.
Benefits
Dental, Medical, Vision and 401K
Numbers & Facts
Location
Auburn, Maine
Skills
Clinical Researchunmatched
Clinical Trialunmatched
Clinical Trial Managementunmatched
Communication Skillsunmatched
Data Analysisunmatched
Data Qualityunmatched
Detail Orientedunmatched
Documentationunmatched
FDA (Food and Drug Administration)unmatched
Microsoft Officeunmatched
Organizational Skillsunmatched
Presentation/Verbal Skillsunmatched
Regulationsunmatched
Team Lead/Managerunmatched
Writing Skillsunmatched
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