TMF Manager

Allen Spolden; City of Auburn (NY); On-site; USD 95,000 - 125,000; Full time

Job summary

Zohorecruit seeks a TMF Manager to lead a team of TMF professionals in an office-based setting. You will drive TMF strategy, ensure high-quality documentation, and collaborate with trial teams to support regulatory readiness including audits and inspections.

Reporting to senior leadership, you will oversee TMF processes across studies, ensuring consistency and quality of documentation to facilitate regulatory submissions and trial success.

Qualifications

• Minimum 5 years of TMF experience.
• High attention to detail.
• Excellent organizational skills.
• Strong written and verbal communication skills.

Responsibilities

• Ensure TMF consistency across projects and clients.
• Present TMF processes to clients, auditors, and inspectors.
• Lead and develop the TMF team (Associates and Administrators).

Skills

TMF management

Quality oversight

Regulatory compliance

Team leadership

Job description

• Industry Nonprofit Charitable Organizations
• Work Experience 1-3 years
• City Auburn
• State/Province Maine
• Country United States

Job Description

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.

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

• 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