Vera Therapeutics, Inc. logo
Vera Therapeutics, Inc.

We are a clinical-stage biotechnology company developing treatments that transform patients’ lives.

TMF Manager, Clinical QA

QA EngineerQA EngineerFull TimeRemoteLeadTeam 201-500H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

40 days ago

Salary

$104K - $159K / year

Seniority

Lead

Bachelor Degree8 yrs expEnglishGoogle Cloud Platform

Job Description

TMF Manager, Clinical QA

Vera Therapeutics, Inc.

• Provide oversight of Trial Master File management across clinical development programs and functions. • Partner closely with Clinical Operations, Clinical Supply Chain, Data Management, Pharmacovigilance, Regulatory Affairs, and other development functions to ensure essential clinical documentation is appropriately maintained within the TMF. • Facilitate periodic TMF health discussions and ensure alignment on TMF quality and completeness expectations. • Interface with CROs and external vendors responsible for TMF activities and contributes to maintaining TMF inspection readiness across the organization. • Support TMF lifecycle activities including study start-up planning, ongoing TMF maintenance, study closeout, and TMF archival in accordance with regulatory and company retention requirements. • Establish and maintain consistent TMF management practices across studies and programs. • Conduct routine TMF health reviews and collaborate with study teams and document content owners to identify documentation gaps and ensure appropriate remediation. • Oversee quality, completeness, and timeliness of Trial Master File (TMF/eTMF) documentation across clinical studies. • Develop 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. • Support regulatory inspections and internal audits involving TMF records and management. • 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 owner and IT or system support teams to implement system improvements in accordance with required change control and validation procedures.

Job Requirements

  • Bachelor’s degree plus 8 Years experience in life sciences, pharmacy, or related 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 related to clinical trial documentation and Trial Master File management.
  • Trial Master File (TMF) oversight 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.

Benefits

  • Health insurance
  • 401(k) matching
  • Flexible work hours
  • Paid time off
  • Remote work options

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