Manager, Records Management – TMF Quality Control Specialist

📋 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 ensure that TMFs and CTMS for clinical studies are always inspection-ready.

• Review study documents provided by study teams for completeness and accuracy before uploading 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 adequately remediated and offer best practice recommendations as necessary.

• Facilitate TMF educational workshops and training sessions as required.

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

• Maintain Essential Document Lists (EDLs) on an ongoing basis.

• Carry out secondary reviews of site Essential Document Packages according to applicable SOPs to confirm that sites fulfill 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 TMF QC Tools as necessary to align with evolving business processes, including QC Tool, QC Manual, Doc Owner Manual, and TMF Newsletters.

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

• Assist with activities related to inspections and audits, including preparation and corrective action plans.

⛳️ Requirements

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

• Understanding of the clinical trial process, with experience in managing clinical trial-related documents is essential.

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

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

• Must possess self-motivation, strong organizational skills, attention to detail, and excellent written and verbal communication abilities.

• Proven ability to meet high-performance goals and deadlines in a fast-paced environment.

• Exceptional organizational skills with a keen attention to detail and follow-through.

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

• Demonstrated proactive problem-solving approaches with strong decision-making skills.

• Proficiency in MS Office Suite and internet research is required.

🏝️ Benefits

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

• Generous paid time off.

• Retirement plan options.

• Additional wellness and professional development programs.