Full-Time

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

Biotechnology

Mid

Oakland, CA, USA

Required Skills
Communications
Requirements
  • 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
Responsibilities
  • 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

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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

IPO

Total Funding

$595M

Headquarters

Emeryville, California

Founded

2013

Growth & Insights
Headcount

6 month growth

18%

1 year growth

20%

2 year growth

38%