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eTMF Manager

2 months ago

San Jose, California, United States KlinEra Global Services Inc Full time

Qualifications

  • Bachelor's degree in life science/related field, advanced degree preferred
  • Minimum of 3+ years in clinical research industry Minimum of 1+ year of eTMF experience
  • Excellent organizational, communication, and problem-solving skills
  • Ability to work independently and collaboratively in a fast-paced environment
  • Proficiency in using eTMF systems (e.g., Veeva Vault, Phlexglobal, Wingspan)

    Responsibilities
    • Maintain and administer the electronic Trial Master File (eTMF) system
    • Ensure the system is validated and compliant with regulatory guidelines (e.g., ICH GCP, FDA, EMA)
    • Configure and optimize the eTMF system to meet project-specific needs.
    • Oversee the uploading, indexing, and organization of essential documents into the eTMF
    • Ensure completeness, accuracy, and timeliness of document filing and metadata entry
    • Monitor document status and track document versions throughout the trial
    • Perform regular quality checks and audits of the eTMF to ensure data integrity and compliance
    • Support internal and external inspections and audits related to the eTMF
    • Provide training to study teams and stakeholders on eTMF processes and best practices
    • Offer technical support and troubleshooting for eTMF system users
    • Collaborate with cross-functional teams (e.g., Clinical Operations, Regulatory Affairs) to ensure alignment on eTMF requirements and timelines
    • Identify opportunities for process improvement and efficiency gains within eTMF management
    • Stay updated on industry trends, regulatory changes, and best practices