TMF Specialist
Position: Contract Trial Master File (TMF) Specialist
Location: Remote ideally west coast candidates
10% traveling to SF and/or SD for quarterly meetings required
Duration: 6 month contract
Overview:
Seeking an experienced TMF Specialist to manage paper and electronic Trial Master Files across clinical studies. This role supports TMF operations, ensuring quality, timeliness, and compliance in collaboration with internal teams, CROs, and TMF vendors.
Key Responsibilities:
• Manage in-house TMF operations to support clinical development.
• Oversee study TMF plans, indexes, and configurations with CRO partners and vendors.
• Ensure TMF quality, completeness, and regulatory compliance throughout study lifecycles.
• Maintain TMF processes, procedures, training materials, and system performance.
• Conduct quality control of TMF documents and support inspection readiness activities.
• Monitor TMF metrics, KPIs, and implement process improvements.
• Serve as eTMF business administrator (Veeva Vault).
Qualifications:
• Bachelor’s degree in Life Sciences or advanced degree.
• 4+ years’ experience managing eTMF systems, including Veeva Vault.
• Strong knowledge of TMF Reference Model, clinical processes, and GCP requirements.
• Proven planning, organizational, and problem-solving skills in a fast-paced environment.
• Inspection readiness experience strongly preferred.
• Excellent written and verbal communication skills.
Apply Now
Apply Now
Location: Remote ideally west coast candidates
10% traveling to SF and/or SD for quarterly meetings required
Duration: 6 month contract
Overview:
Seeking an experienced TMF Specialist to manage paper and electronic Trial Master Files across clinical studies. This role supports TMF operations, ensuring quality, timeliness, and compliance in collaboration with internal teams, CROs, and TMF vendors.
Key Responsibilities:
• Manage in-house TMF operations to support clinical development.
• Oversee study TMF plans, indexes, and configurations with CRO partners and vendors.
• Ensure TMF quality, completeness, and regulatory compliance throughout study lifecycles.
• Maintain TMF processes, procedures, training materials, and system performance.
• Conduct quality control of TMF documents and support inspection readiness activities.
• Monitor TMF metrics, KPIs, and implement process improvements.
• Serve as eTMF business administrator (Veeva Vault).
Qualifications:
• Bachelor’s degree in Life Sciences or advanced degree.
• 4+ years’ experience managing eTMF systems, including Veeva Vault.
• Strong knowledge of TMF Reference Model, clinical processes, and GCP requirements.
• Proven planning, organizational, and problem-solving skills in a fast-paced environment.
• Inspection readiness experience strongly preferred.
• Excellent written and verbal communication skills.
Apply Now
Apply Now