Associate Director, Trial Master File

Structuretx is seeking an Associate Director, Trial Master File (TMF) to lead and oversee TMF operations within our clinical development team. This pivotal role ensures that all clinical trial documentation is managed in compliance with regulatory standards and is inspection-ready at all times. The Associate Director will collaborate closely with cross-functional teams to maintain the integrity and quality of the TMF.

The primary responsibilities include developing and implementing TMF strategies, overseeing the maintenance and quality control of TMF documents, and ensuring adherence to ICH-GCP guidelines and company SOPs. The role involves managing TMF processes across multiple clinical studies, coordinating with internal teams and external vendors, and preparing for regulatory inspections.

Candidates should possess a Bachelor's degree in a related field and have a minimum of 8 years of experience in clinical operations, with significant expertise in TMF management. Strong knowledge of regulatory requirements, proficiency with electronic TMF systems, and excellent organizational and leadership skills are essential.

Structuretx offers a competitive compensation package, including a salary range of $155,000 to $190,000 annually, along with comprehensive benefits such as health insurance, 401(k) matching, and paid time off.

Joining Structuretx means becoming part of a dynamic and innovative company dedicated to advancing clinical research and improving patient outcomes. We foster a collaborative and inclusive work environment with opportunities for professional growth and development.