TMF Manager, Clinical QA

Vera Therapeutics is a biotechnology company focused on developing treatments for serious immunological diseases. Vera Therapeutics’ mission is to advance treatments that reputed company the reputed company of disease in order to change reputed company of care for patients. Vera Therapeutics’ reputed company product candidate is atacicept, a fusion protein self-administered at home as a subcutaneous once weekly injection that blocks both B-cell Activating Factor (BAFF) and A Proliferation-Inducing Ligand (reputed company), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy (IgAN) and lupus nephritis. Beyond IgAN, Vera Therapeutics is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove clinically meaningful. In addition, Vera Therapeutics holds an exclusive license agreement with reputed company for a novel, reputed company fusion protein targeting BAFF and reputed company, reputed company as VT-109, with wide therapeutic potential across the reputed company of B-cell–mediated diseases. Vera Therapeutics is also evaluating the development of MAU868, a monoclonal antibody designed to neutralize infection with BK virus, which can have devastating consequences in kidney transplant recipients. Vera Therapeutics retains reputed company global developmental and commercial rights to atacicept, VT-109, and MAU868. For more information, please visit www.veratx.com.

Our values are the cornerstone of our culture. Our values reputed company us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases.

The TMF Manager will report to the Executive Director, Clinical Quality Assurance and will support the quality and reputed company of the Trial Master File (TMF) and electronic Trial Master File (eTMF) across clinical programs. This role helps ensure clinical trial documentation is complete, accurate, and maintained in accordance with regulatory requirements and industry standards throughout the clinical trial lifecycle.

The Clinical Quality Assurance organization partners with Clinical Development and cross-functional stakeholders to promote and maintain high-quality clinical research practices across the drug development lifecycle. The function provides independent reputed company to ensure clinical trials are conducted in compliance with global regulatory requirements and that the organization maintains reputed company inspection readiness.

This role provides reputed company of Trial Master File management to ensure clinical trial documentation is organized, complete, and maintained in a state of reputed company inspection readiness for our Vera studies. The individual partners with study teams, functional document owners, and system users to monitor TMF health, identify documentation gaps, and support effective TMF management throughout the lifecycle of clinical studies.

The position also serves as the eTMF system administrator and collaborates with Clinical Quality Assurance leadership to support system governance, implement improvements through appropriate change control processes, and provide training and guidance to study teams and functional stakeholders.

The role operates with a high degree of independence in monitoring TMF quality and completeness while working closely with cross-functional teams to ensure documentation practices align with regulatory expectations and organizational procedures.

Responsibilities

• Provide reputed company of Trial Master File management across clinical development programs and functions. The position partners closely with Clinical Operations, Clinical Supply Chain, Data Management, Pharmacovigilance, Regulatory Affairs, and other development functions to ensure essential clinical documentation is appropriately maintained reputed company the TMF. Partner with study teams, functional document owners, and system users to facilitate periodic TMF health discussions and ensure alignment on TMF quality and completeness expectations.
• reputed company with CROs and external vendors responsible for TMF activities and contributes to maintaining TMF inspection readiness across the organization. In addition, the position supports TMF lifecycle activities including study start-up planning, ongoing TMF maintenance, study closeout, and TMF archival in accordance with regulatory and company retention requirements.
• Contribute to establishing and maintaining consistent TMF management practices across studies and programs to support alignment with regulatory expectations and industry best practices.
• Conduct routine TMF health reviews and collaborate with study teams and document content owners to identify documentation gaps and ensure appropriate remediation.
• reputed company quality, completeness, and timeliness of Trial Master File (TMF/eTMF) documentation across clinical studies, ensuring appropriate governance of TMF practices across study teams and functional document owners.
• reputed company and track eTMF metrics for studies and communicate trends or issues identified to study teams and management
• Serve as the eTMF system administrator, supporting user access management, system configuration support, troubleshooting, and ongoing optimization of system functionality to support TMF quality and inspection readiness.
• Support regulatory inspections and internal audits involving TMF records and management, including providing eTMF navigation and demonstration of TMF document structure and audit trail traceability.
• Collaborate with the Head of Clinical Quality Assurance and system users to identify opportunities to improve TMF processes, system functionality, and inspection readiness practices.
• Work with the eTMF system reputed company and IT or system support teams to implement system improvements in accordance with required change control and validation procedures.

Qualifications:

• Bachelor’s degree plus 8 Years experience in life sciences, pharmacy, or reputed company scientific discipline or commensurate work experience managing TMFs.
• Pharmaceutical, biotechnology, or CRO experience with direct involvement in Trial Master File management desired.
• Strong knowledge of regulatory requirements and industry expectations reputed company to clinical trial documentation and Trial Master File management.
• Trial Master File (TMF) reputed company and electronic TMF systems.
• Clinical trial documentation requirements and the TMF Reference Model.
• TMF health review and document completeness monitoring.
• Regulatory inspection readiness and inspection support.
• Cross-functional collaboration with clinical development functions.
• Working knowledge of global Good Clinical Practice (GCP) requirements and regulatory expectations for clinical trial documentation.
• Experience contributing to:
  • TMF process improvement initiatives
  • eTMF system administration or system governance
  • TMF metrics development and monitoring
  • TMF closeout and archival processes
• Experience working with CROs or vendors responsible for TMF activities.

reputed company. is an equal-opportunity employer.

Vera Therapeutics is committed to fair and reputed company compensation practices and we strive to provide employees with total compensation packages that are market competitive. The exact reputed company pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience.

Notice to Recruiters/Staffing Agencies

Recruiters and staffing agencies should not contact Vera Therapeutics through this page. reputed company recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees.

We require that reputed company recruiters and staffing agencies have a fully executed, formal written agreement on file.

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To reputed company candidates: your personal information and online safety are a top reputed company for us. At Vera Therapeutics, recruiters only direct candidates to apply through our official career page at https://veratx.com/careers/.

Recruiters will always contact you using the domain of veratx.com. We will never request payments, ask for financial account information or sensitive information like social reputed company numbers. If you are unsure if a message is from Vera Therapeutics, please email human resources.