Senior TMF Compliance & Records Lead

Codera; San Diego (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

Codera is seeking a Manager, Records Management to ensure TMF documents comply with SOPs, ICH-GCP guidelines, and regulatory requirements. This role acts as TMF SME and collaborates with study teams to keep TMFs and CTMS inspection-ready at all times.

Key duties include document review, TMF quality control, remediation of issues, and delivering trainings to study teams on good documentation practices for clinical trials.

Qualifications

• Must have strong attention to detail and the ability to manage multiple priorities.
• Excellent written and verbal communication skills are required.
• Well-organized with a proactive approach to problem-solving in a fast-paced environment.
• Solid understanding of ICH-GCP guidelines and regulatory requirements for clinical document management.
• Experience with TMF processes and electronic TMFs preferred.

Responsibilities

• Review study documents for completeness and upload to the TMF.
• Perform quality control of TMF documents per SOPs and guidance.
• Remediate TMF quality issues and provide best practice recommendations.
• Conduct TMF quality reviews to ensure inspection readiness.
• Provide training on good documentation management practices.

Skills

Attention to detail

Communication skills

Organization

Regulatory knowledge

Problem solving

Tools

Veeva

CTMS

MS Office

Job description

Codera is seeking a Manager, Records Management to ensure TMF documents comply with SOPs, ICH-GCP guidelines, and regulatory requirements. This role acts as TMF SME and collaborates with study teams to keep TMFs and CTMS inspection-ready at all times.

Key duties include document review, TMF quality control, remediation of issues, and delivering trainings to study teams on good documentation practices for clinical trials.