Job Title

Clinical Trial Master File (TMF) ManagerGreater Toronto Area / HybridGreater Montreal Area / HybridOur 3 Core Values Intelligence Integrity InitiativeOur mission is to harness the immune system through innovative cell therapies and other modalities to deliver widely accessible cures. Patients are waiting! What You'll DoAs a TMF Manager you will perform a comprehensive eTMF completeness check/periodic or milestone review and focus on cross checks, codependency checks and identify missing documents in the eTMF.Ensure eTMF is inspection ready for all allocated studies.Conduct completeness check and update the expected document list when required.Perform ALCOA+ and metadata check to ensure accuracy and compliance.Liaise with study teams and other TMF staff to fulfill job responsibilities and activities.Set-up and Maintain eTMF in real time following internal SOPs.Complete departmental projects as assigned in accordance with specified timelines, SOPs/WPs and regulations.Maintain study files in accordance with SOPs.Complete activities related to document receipt and processing which may include but is not limited to: document receipt and review, scanning and indexing, quality control, copying, filing, forwarding or return to client/study teams and archiving.Provide information necessary to complete client and/or departmental status reports.Inform head of clinical operations of training issues, project activities, quality issues and timelines as directed.Conduct training for study team members (new and existing) on eTMF.Participate in audits and document archiving activities as necessary.Participate in training related to fulfillment of responsibilities as required by company.What We Look For2+ years of managing a team with TMF (Trial Master File) experience and strong knowledge of Clinical Studies documents.Minimum of 5 years of experience in TMF and periodic review.Thorough understanding of FDA regulations.Full working knowledge of eTMF reference modelKnowledge of GCP compliance for Clinical Trials.TMF (Trial Master File) experience and strong knowledge of Clinical Studies documents.Ability to successfully liaise with study project teams, staff, and management, as necessary.Bachelors Degree in Life Science preferred.About Nexcella Nexcella Inc., a wholly-owned Immix Biopharma subsidiary, is a clinical-stage biopharmaceutical company trailblazing cell therapies in AL Amyloidosis and other serious diseases. Our lead candidate is sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201.Learn more at