The Role
The TMF Manager oversees the Trial Master File processes, ensures high quality and consistency, leads a team, and participates in audits and inspections.
Summary Generated by Built In
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.
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
Skills Required
- 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
- Knowledge of MS Office
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The Company
What We Do
Allen Spolden specializes in clinical research operations management and provides tailored workforce solutions for clinical research organizations, pharmaceutical, biotech, and healthcare sectors. They offer services in clinical research, data management, regulatory affairs, and talent acquisition.
