Lead TMF Records Management – Inspection-Ready Trials

Codera, LLC; United States; Remote; USD 110,000 - 160,000; Full time

Job summary

Remote Jobs seeks a Manager, Records Management to support TMF activities, ensuring documents meet SOPs, ICH GCP guidelines, and regulatory standards. This TMF SME will collaborate with study teams to keep TMFs and CTMS inspection-ready at all times.

Responsibilities include document review, QC, remediation of quality issues, TMF workshops, CTMS maintenance, and ongoing training to promote best practices in clinical documentation.

Qualifications

• Minimum 2 years of relevant clinical research and TMF experience required.
• Understanding of the clinical trial process and TMF documentation.
• Experience with electronic TMFs; Veeva preferred.
• Strong knowledge of ICH-GCP guidelines and regulatory requirements.
• Self-motivated, organized, detail oriented, with strong written/verbal skills.

Responsibilities

• Review study documents for completeness and upload to the TMF.
• Perform QC of TMF submissions per SOPs and guidelines.
• Remediate TMF quality issues and provide best-practice recommendations.
• Ensure TMFs are inspection ready; maintain CTMS updates.
• Provide training and workshops on TMF practices.
• Maintain up-to-date TMF references and participate in audits.

Skills

TMF knowledge

Documentation management

Quality control

Regulatory compliance

Attention to detail

Communication skills

Tools

Veeva

MS Office Suite

Job description

Remote Jobs seeks a Manager, Records Management to support TMF activities, ensuring documents meet SOPs, ICH GCP guidelines, and regulatory standards. This TMF SME will collaborate with study teams to keep TMFs and CTMS inspection-ready at all times.

Responsibilities include document review, QC, remediation of quality issues, TMF workshops, CTMS maintenance, and ongoing training to promote best practices in clinical documentation.