Manager, Records Management – TMF Quality Control Specialist

Codera

Manager for TMF Quality Control at Codera ensuring document compliance for clinical trials while acting as a subject matter expert and providing training to study teams.

Posted 5/5/2026full-timeRemote • California • 🇺🇸 United StatesJuniorMid-Level💰 $115,000 - $145,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Provide support for TMF activities by ensuring documents uploaded to the TMF adhere to Standard Operating Procedures, ICH GCP guidelines and other regulatory requirements
Act as a TMF Subject Matter Expert (SME) and work with the study teams to ensure the TMFs and CTMS for clinical studies are inspection ready at all times
Review study documents received from the study teams for completeness and accuracy and upload to the Trial Master File (TMF)
Perform quality control of documents submitted to the TMF per SOPs, Work Instructions and Guidance Documents
Ensure documents which fail TMF quality control and/or TMF quality review are effectively remediated and provide best practice recommendations, as needed
Conduct TMF educational workshops/training, as needed
Address TMF questions pertaining to how documents are filed, and user questions related to the TMF system
Ensure Essential Document Lists (EDLs) are maintained on an ongoing basis
Perform the secondary review of site Essential Document Packages per applicable SOPs to ensure sites meet the requirements for site activation and Investigational Product (IP) release
Responsible for Clinical Trial Management System (CTMS) maintenance, including study, country and site level updates and reviewing CTMS entries for accuracy
Contribute to TMF QC Tools as needed to match with evolving business processes (incl. QC Tool, QC Manual, Doc Owner Manual, TMF Newsletters)
Maintain up to date knowledge of the TMF Reference Model, industry best practices and regulatory considerations as applicable to the job duties
Assist with inspection/audit related activities (e.g., preparation, corrective action plans)

Requirements

What you’ll need

Minimum 2 years of relevant clinical research and TMF experience required
Understanding of the clinical trial process, experience in 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
Must be self-motivated, well-organized, detail-oriented, and have excellent written and verbal communication skills
Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment
Strong organization skills with outstanding attention to detail and follow-through
Must be highly resourceful and adaptable to effectively support multiple competing demands and changing priorities
Demonstrated proactive approaches to problem-solving with strong decision-making capabilities
Must be fully proficient in MS Office Suite and internet research.

Benefits

Comp & perks

employer sponsored insurance plans including medical, dental and vision coverage
generous paid time off
retirement plan options
additional wellness and professional development programs

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical researchTrial Master File (TMF)Clinical Trial Management System (CTMS)quality controldocument managementICH-GCP guidelinesregulatory requirementselectronic TMFsVeevainspection readiness

Soft Skills

self-motivatedwell-organizeddetail-orientedexcellent written communicationexcellent verbal communicationstrong organization skillsattention to detailproblem-solvingdecision-makingadaptability