TMF Operations Specialist

We’re looking for a highly organized and detail‐oriented TMF Specialist to join our Clinical Operations team and play a key role in ensuring excellence across our clinical documentation processes. In this role, you will be responsible for the end‐to‐end management, oversight, and quality of the Trial Master File (TMF), ensuring compliance with regulatory requirements and internal standards.

Requirements

• Bachelor’s degree in Life Sciences, Clinical Research, or a related field.
• Minimum of 3-5 years of experience in TMF management within the pharmaceutical or CRO industry.
• Strong understanding of ICH-GCP guidelines and regulatory requirements for clinical trials.
• Excellent organizational, communication, and interpersonal skills.
• Proficiency in TMF management systems, specifically Veeva, and Microsoft Office Suite.
• Attention to Detail: High level of accuracy and attention to detail in managing documentation.
• Problem-Solving: Ability to identify and resolve issues related to TMF management.

Benefits

• Professional development opportunities
• Competitive salary and benefits package