TMF Records Manager – Clinical Trial Documentation Lead

Artech Information System LLC; Swiftwater (Monroe County); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading IT staffing company is seeking a Records Manager responsible for overseeing clinical documentation related to study TMFs. The role involves supervising study TMF setup, ensuring quality control of documents, and supporting the clinical team with TMF management processes. Ideal candidates should have at least one year of clinical research experience and a Bachelor's Degree. Strong interpersonal skills and fluent English communication are required. This position offers the chance to contribute to meaningful clinical projects.

Qualifications

• At least 1 year of experience in clinical research is required.
• Very good knowledge of TMF regulations, ICH guidelines, and regulatory agency documents.
• Ideally, previous experience as a Records Manager or Clinical Research Associate is preferred.

Responsibilities

• Oversee clinical documentation management activities.
• Supervise study TMF set-up and develop trial-specific documentation.
• Support documentation teams and ensure TMF document quality.
• Monitor TMF completeness and provide progress reports.
• Act as a point of contact for TMF management processes.

Skills

Knowledge of the clinical development process

Knowledge of TMF regulations

Knowledge of the Code of Federal Regulations

Fluent English communication skills

Very good interpersonal skills

Education

Bachelor's Degree or equivalent qualification/experience

Job description

A leading IT staffing company is seeking a Records Manager responsible for overseeing clinical documentation related to study TMFs. The role involves supervising study TMF setup, ensuring quality control of documents, and supporting the clinical team with TMF management processes. Ideal candidates should have at least one year of clinical research experience and a Bachelor's Degree. Strong interpersonal skills and fluent English communication are required. This position offers the chance to contribute to meaningful clinical projects.