Clinical Records Associate

TMF Operations

Confirmed live in the last 24 hours

4D Molecular Therapeutics

4D Molecular Therapeutics

51-200 employees

Develops gene therapy products for serious diseases



Oakland, CA, USA

Required Skills
  • Bachelor's degree in a scientific or healthcare-related field or 4 years of relevant training and work experience
  • 2 years of relevant experience including extensive experience with Veeva Vault TMF
  • 2+ years of TMF QC Review and knowledge of clinical documentation content
  • Experience with development and maintenance of TMF Plans
  • Understanding of the DIA Reference Model filing structure and contents
  • Knowledge of applicable regulations and guidelines (e.g., ICH/GCP/Good Documentation Practice)
  • Experience working with cross-functional teams to improve TMF compliance
  • Expert knowledge of cross-functional TMF content requirements
  • Proficiency in Microsoft Office Suite, especially Excel
  • Excellent communication skills
  • Strong attention to detail and organizational skills
  • Analytical skills to evaluate complex situations
  • Experience managing CROs performing TMF activities
  • Experience with Veeva products, collaborative tools like SharePoint and Microsoft Teams
  • Ensure compliance with global and local standards for clinical documentation
  • Manage TMF performance objectives for quality and completeness
  • Oversee TMF lifecycle for all clinical trials
  • Participate in audits and inspections
  • Support Study Teams in maintaining Expected Documents List
  • Identify and resolve TMF compliance gaps
  • Manage external vendors for TMF-related deliverables
  • Collaborate cross-functionally for process improvements
  • Contribute to SOP development and improvement
  • Perform other assigned duties

4D Molecular Therapeutics

4D Molecular Therapeutics


4D Molecular Therapeutics, a clinical stage biopharma company, excels in genetic medicine with a focus on curative therapies across various specialties such as ophthalmology, pulmonology, and cardiology. They leverage a unique vector discovery platform, Therapeutic Vector Evolution, which employs directed evolution to design uniquely effective vectors. This commitment to tailored therapeutic solutions and cutting-edge technology makes it an exceptional workplace for professionals passionate about pioneering in the field of genetic medicine and contributing to significant advancements in healthcare.

Company Stage


Total Funding



Emeryville, California



Growth & Insights

6 month growth


1 year growth


2 year growth