We are a clinical-stage biotechnology company developing treatments that transform patients’ lives.
TMF Manager, Clinical QA
Location
United States
Posted
40 days ago
Salary
$104K - $159K / year
Seniority
Lead
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
Related Guides
Related Categories
Related Job Pages
More QA Engineer Jobs
RCM QA Specialist – Cash Posting
ResMedPioneering innovative medical device and digital health solutions that treat and keep people out of the hospital.
• Accurately and timely post cash payments received from various sources, including insurance companies, patients, and other payers, into the billing system. • Conduct thorough cash posting and denial posting processes, ensuring accuracy and adherence to established procedures. • Reconcile accounts and resolve discrepancies in cash postings to ensure accurate financial records. • Maintain a comprehensive understanding of US payer contracts, EOB/ERA codes, and adjustments to accurately apply payments and adjustments. • Stay updated with changes in reimbursement policies, payer contracts, and industry regulations related to cash posting. • Maintain documentation of cash posting processes, procedures, and payer-specific guidelines. • Participate in team meetings and provide input for process improvement initiatives.
QA Analyst – Quality Assurance
Giro.TechA Giro.Tech cria os bancos do futuro! Transformamos startups e empresas não financeiras em fintechs de crédito.
• We are looking for a Mid-level QA Analyst to work with our technology and operations teams. • Your main mission will be to have full command of our operations team's responsibilities, understand the systems in use and map improvement opportunities. • Master the business characteristics of bancarization (banking) and securitization. • Plan and execute manual and automated tests (API, integration, and regression). • Write and maintain clear, well-organized test cases using QA management tools. • Test our APIs and partner integrations, validating end-to-end flows. • Define and track quality metrics: production bug rate, test coverage, regression time, bugs by severity. • Actively participate in sprint ceremonies, collaborating on acceptance criteria and validating deliveries with the development team. • Create process automations using AI tools, always seeking to automate day-to-day tasks not yet addressed by our systems.
• Evaluate AI-generated images to ensure: - Correct scale and proportions - Accurate product structure and details (e.g., arms, blades, components) - Consistent and realistic color, material, and finish - Proper placement within room or lifestyle settings • Ensure images meet brand, client, and industry standards • Approve images that meet quality standards for client delivery • Reject images with major inaccuracies or structural issues • Apply quick fixes to minor issues (within a maximum of 5 minutes per image) • Perform light editing tasks such as: - Adjusting dimension arrows and labels - Fixing minor alignment issues - Removing small visual artifacts or inconsistencies • Ensure all edits maintain realism and product accuracy • Identify recurring quality issues in AI outputs • Provide structured feedback to improve: - AI prompts - Image generation workflows • Collaborate with internal teams to enhance output quality over time
QA Optimization, AI Developer
Uproar by MoburstHigh-impact PR that puts your brand in front of the right people.
• Conduct audits of AI-generated outputs across large-scale deployments to ensure data accuracy, formatting consistency, and logical flow. • Monitor active AI agents and automation workflows; identify, diagnose, and resolve technical bottlenecks or API-related failures. • Collaborate with internal teams and clients to identify operational gaps and implement technical fixes that enhance tool reliability and user experience. • Utilize platforms such as Cursor and Claude to refine existing code, troubleshoot logic, and implement technical fixes that enhance tool reliability.




