Manager/Senior Manager, Records Management

Codera

. Review study documents received from study teams for completeness and accuracy and upload them to the Trial Master File (TMF) .

Posted 9/22/2026full-timeRemote • California • United StatesSenior💰 $110,000 - $160,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Clinical Trial Management and Trial Master File (TMF) processes, ensuring compliance with ICH-GCP guidelines and regulatory requirements. Proficient in quality control, document management, and training study teams on best practices.

Highest-signal resume keywords

Clinical Research ExperienceTrial Master File (TMF) ManagementICH-GCP Guidelines KnowledgeElectronic TMF Systems (Veeva)MS Office Suite Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality ControlDocument ManagementRegulatory ComplianceClinical Trial Process UnderstandingEssential Document Lists (EDLs) MaintenanceTMF Educational WorkshopsInspection ReadinessCorrective Action PlansTMF QC Tools DevelopmentSecondary Review of Essential Document Packages

Soft Skills

Detail-OrientedExcellent Communication SkillsOrganizational SkillsProactive Problem-SolvingAdaptability

Tools & Technologies

Trial Master File (TMF)Clinical Trial Management System (CTMS)VeevaQC ToolQC Manual

Industry Keywords

Clinical Document ManagementRegulatory RequirementsSOPsBest PracticesInspection and Audit Activities

About the role

Key responsibilities & impact

Review study documents received from study teams for completeness and accuracy and upload them to the Trial Master File (TMF)
Perform quality control and quality reviews of TMF documents according to SOPs, work instructions, and guidance documents
Ensure documents failing TMF quality control or review are remediated and provide best-practice recommendations
Support TMF and CTMS inspection readiness for clinical studies
Provide feedback, support, and training to study teams on quality documentation management practices
Conduct TMF educational workshops and training as needed
Address questions about document filing and TMF system use
Maintain Essential Document Lists (EDLs)
Perform secondary review of site Essential Document Packages for site activation and Investigational Product release
Maintain the Clinical Trial Management System (CTMS), including study-, country-, and site-level updates, and review entries for accuracy
Contribute to TMF QC tools and materials, including the QC Tool, QC Manual, Doc Owner Manual, and TMF newsletters
Maintain current knowledge of the TMF Reference Model, industry best practices, and applicable regulatory considerations
Assist with inspection and audit activities, including preparation and corrective action plans
Execute other duties as assigned

Requirements

What you’ll need

Minimum 2 years of relevant clinical research and TMF experience required
Understanding of the clinical trial process and experience handling clinical trial-related documents required
Previous experience in electronic TMFs; Veeva preferred
Strong knowledge of ICH-GCP guidelines and regulatory requirements related to clinical document management
Self-motivated, well-organized, detail-oriented, with excellent written and verbal communication skills
Ability to achieve high performance goals and meet deadlines in a fast-paced environment
Strong organizational skills with outstanding attention to detail and follow-through
Highly resourceful and adaptable to effectively support multiple competing demands and changing priorities
Proactive approach to problem-solving with strong decision-making capabilities
Fully proficient in MS Office Suite and internet research