eTMF Manager - KlinEra Global Services Inc

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