Manager, Records Management – TMF Quality Control Specialist

This is a fully remote position, open to applicants in California.

📋 Description

• Support TMF activities by ensuring that documents uploaded to the TMF comply with Standard Operating Procedures, ICH GCP guidelines, and other regulatory requirements.

• Serve as a TMF Subject Matter Expert (SME) and collaborate with study teams to guarantee that the TMFs and CTMS for clinical studies are always inspection-ready.

• Review study documents submitted by study teams for completeness and accuracy, and upload them to the Trial Master File (TMF).

• Conduct quality control on documents submitted to the TMF in accordance with SOPs, Work Instructions, and Guidance Documents.

• Ensure that documents failing TMF quality control and/or TMF quality review are remediated effectively and provide best practice recommendations when necessary.

• Facilitate TMF educational workshops and training sessions as required.

• Address queries regarding TMF document filing and respond to user inquiries related to the TMF system.

• Maintain Essential Document Lists (EDLs) consistently.

• Perform secondary reviews of site Essential Document Packages according to applicable SOPs to confirm that sites meet the requirements for site activation and Investigational Product (IP) release.

• Oversee Clinical Trial Management System (CTMS) maintenance, including updates at the study, country, and site levels, and review CTMS entries for accuracy.

• Contribute to the development of TMF QC Tools as required to align with evolving business processes (including QC Tool, QC Manual, Doc Owner Manual, TMF Newsletters).

• Maintain current knowledge of the TMF Reference Model, industry best practices, and regulatory considerations relevant to job responsibilities.

• Assist with activities related to inspections and audits (e.g., preparation, corrective action plans).

⛳️ Requirements

• A minimum of 2 years of relevant clinical research and TMF experience is required.

• Understanding of the clinical trial process and experience in managing clinical trial-related documents are essential.

• Prior experience with electronic TMFs, particularly Veeva, is preferred.

• Strong knowledge of ICH-GCP guidelines and regulatory requirements connected to clinical document management is necessary.

• Must be self-motivated, organized, detail-oriented, and possess excellent written and verbal communication skills.

• Proven ability to achieve high performance goals and meet deadlines in a dynamic environment.

• Strong organizational skills with exceptional attention to detail and follow-through are required.

• Must be highly resourceful and adaptable to effectively manage multiple competing demands and changing priorities.

• Demonstrated proactive problem-solving approaches with strong decision-making abilities are needed.

• Must be fully proficient in the MS Office Suite and internet research.

🏝️ Benefits

• Employer-sponsored insurance plans including medical, dental, and vision coverage.

• Generous paid time off.

• Retirement plan options.

• Additional wellness and professional development programs.