Clinical Trial Specialist

eTMF Specialist

Salary: $85,000- $100,000

A fast-growing biotech is seeking a highly organized and detail-oriented eTMF Specialist with extensive experience in Veeva to manage and oversee the electronic Trial Master File (eTMF) system for a small biotech with a robust pipeline and strong financial runway. The ideal candidate will be responsible for ensuring compliance with regulatory requirements, maintaining high-quality documentation, and supporting clinical trial operations. This role is critical to the success of our clinical trials and will work closely with various departments to ensure the accuracy and completeness of the eTMF.

Key Responsibilities:

• Manage the setup, maintenance, and quality control of the electronic Trial Master File (eTMF) system using Veeva.
• Ensure all clinical trial documentation is collected, reviewed, and filed in accordance with regulatory requirements and company SOPs.
• Conduct regular eTMF quality reviews and audits to ensure compliance and completeness.
• Coordinate with clinical operations, quality assurance, and regulatory teams to address documentation needs and discrepancies.
• Provide training and support to team members on eTMF processes and Veeva system usage.
• Assist in the preparation for regulatory inspections and audits.
• Generate eTMF metrics and reports to monitor the status and quality of the eTMF.
• Stay updated with industry best practices and regulatory changes related to eTMF management.

Qualifications:

• Bachelor’s degree in Life Sciences, Health Sciences, or a related field.
• Minimum of 2 years of experience managing eTMF systems, with at least 3 years of experience working in a biotech or Pharmaceutical setting
• Proficiency in Veeva eTMF and other clinical trial management systems.
• Strong understanding of clinical trial processes and regulatory requirements (e.g., ICH-GCP, FDA, EMA).
• Experience in oncology .
• Excellent organizational and communication skills.
• Attention to detail and the ability to manage multiple priorities.
• Experience with quality control and audit processes.
• Ability to work independently and as part of a team.

Benefits:

• Competitive salary and benefits package
• Opportunities for professional growth and development
• Flexible work environment