TMF Specialist: Quality & Compliance Expert

Piper Companies; Bethesda (MD); Hybrid; USD 80,000 - 120,000; Full time

Benefits offered by this job

PTO

Medical, Dental, Vision

401K

Tuition Reimbursement

Paid Holidays

Paid Maternity Leave

Military Reserve Pay Offset

Job summary

Piper Companies is seeking a TMF Specialist to support a leading clinical research and healthcare organization. This hybrid role is based in Bethesda, MD, with collaboration across internal teams, sponsors, and external stakeholders.

The TMF Specialist will manage TMF setup, quality management activities, and ensure documents comply with ICH-GCP, FDA and EMA requirements, while training project teams and supporting audits and inspections.

Qualifications

• Bachelor's degree in science, healthcare, or related field.
• Experience with eTMF systems; Veeva Vault and Trial Interactive preferred.
• Strong understanding of clinical research processes and TMF document management.
• Knowledge of FDA, ICH-GCP, EMA and TMF regulatory requirements.
• Excellent organizational skills and ability to manage multiple priorities.
• Strong written and verbal communication; ability to collaborate across teams.

Responsibilities

• Manage TMF setup, quality management activities, reporting, metrics, and QA processes.
• Ensure clinical trial documentation is complete, filed, and maintained per eTMF standards.
• Coordinate document collection, filing, tracking, and reporting across teams and sponsors.
• Conduct quality control reviews and approve documents for inspection readiness.
• Serve as SME on TMF processes, training and supporting project teams.
• Support audit and inspection readiness activities, including document retrieval and transfers.
• Monitor project timelines and deliverables to ensure quality.

Skills

eTMF processes

Veeva Vault

Trial Interactive

FDA regulations

ICH-GCP

EMA regulations

Regulatory compliance

Organizational skills

Communication skills

Education

Bachelor's degree in science, healthcare, or related field

Tools

Microsoft Office Suite

Job description

Piper Companies is seeking a TMF Specialist to support a leading clinical research and healthcare organization. This hybrid role is based in Bethesda, MD, with collaboration across internal teams, sponsors, and external stakeholders.

The TMF Specialist will manage TMF setup, quality management activities, and ensure documents comply with ICH-GCP, FDA and EMA requirements, while training project teams and supporting audits and inspections.