Senior TMF Records Manager - Clinical Documentation Lead

Artech Information System LLC; Swiftwater (Monroe County); On-site; USD 60,000 - 75,000; Full time

Job summary

A leading IT staffing firm in the United States seeks a Records Manager to oversee Clinical Documentation activities for study TMFs. The successful candidate will supervise TMF setup, support documentation teams, and ensure quality and completeness of TMF documents. Ideal applicants possess strong knowledge of TMF regulations, at least 1 year of clinical research experience, and excellent communication skills. This role demands the ability to coordinate with various team members and provide metrics on TMF progress.

Qualifications

• At least 1 year experience in clinical research.
• Formal training in GCP methods.
• Understanding of TMF regulations and ICH.

Responsibilities

• Supervise the study TMF set-up in the eTMF/EDMS system.
• Provide support to Clinical Documentation Team.
• Monitor TMF completeness and quality.
• Provide expertise on TMF Management Processes.

Skills

Clinical development process knowledge

GCP methods training

TMF regulations understanding

Knowledge of US Federal Regulations

Records Manager or Clinical Research Associate experience

Fluent English communication skills

Very good interpersonal skills

Job description

A leading IT staffing firm in the United States seeks a Records Manager to oversee Clinical Documentation activities for study TMFs. The successful candidate will supervise TMF setup, support documentation teams, and ensure quality and completeness of TMF documents. Ideal applicants possess strong knowledge of TMF regulations, at least 1 year of clinical research experience, and excellent communication skills. This role demands the ability to coordinate with various team members and provide metrics on TMF progress.