eTMF Specialist

Klinera Global Services • San Jose, CA

405d

About The Position

The eTMF Specialist at KlinEra Global Services Inc. is responsible for maintaining and administering the electronic Trial Master File (eTMF) system, ensuring compliance with regulatory guidelines, and optimizing the system for project-specific needs. This role requires a blend of technical expertise and strong organizational skills to support clinical research activities effectively.

Requirements

• Bachelor's degree in life science/related field, advanced degree preferred
• Minimum of 4+ years in clinical research industry
• Minimum of 2+ years 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)

Nice To Haves

• Fluency in Mandarin is preferred. We welcome applicants from diverse linguistic backgrounds

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

What This Job Offers

• Job Type: Full-time
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree