Contract TMF Specialist

Position Summary:
We are seeking a highly skilled and motivated TMF Specialist to manage paper and electronic trial master files for clinical studies. This role involves collaborating with internal teams, CRO partners, and TMF vendors to ensure compliance with study TMF plans and regulatory requirements. The ideal candidate will bring expertise in TMF operations and a passion for advancing therapeutic development.

Location: Remote

Reporting Into: Senior Clinical Operations Leadership

Key Responsibilities:

• Support in-house TMF operations for clinical development activities.
• Collaborate with clinical study teams to manage TMF plans and indexes in partnership with CROs and TMF vendors.
• Partner with cross-functional teams to ensure TMF quality, timeliness, and completeness throughout study lifecycles.
• Maintain TMF configurations, processes, and training materials to comply with regulatory requirements.
• Conduct quality control of TMF documents to meet GCP and regulatory standards from study initiation through closeout and archival.
• Monitor TMF inventory lists, metrics, and periodic reviews per study-specific TMF plans; identify improvement areas and develop process changes as needed.
• Act as eTMF business administrator, optimizing system performance and implementing necessary configuration changes.
• Support TMF-related elements during regulatory inspections by providing relevant documents and responses.

Requirements:

• Bachelor’s degree in Life Sciences or related discipline; advanced degree preferred.
• At least 4 years of experience maintaining eTMF systems.
• Proficiency with eTMF systems, particularly Veeva Vault.
• Strong understanding of TMF reference models and cross-functional clinical processes.
• Excellent organizational and time management skills to handle multiple priorities.
• Self-motivated, with the ability to evaluate and resolve complex problems in a fast-paced environment.
• Deep knowledge of quality and GCP requirements to ensure compliance with ICH GCP and other global regulations.
• Prior experience with inspection readiness is highly desirable.
• Excellent written and verbal communication skills.