TMF Specialist - 174535 - 174535

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

Job Summary:

Piper Companies is seeking a TMF Specialist to support a leading clinical research and healthcare organization. This position is Hybrid in Bethesda, MD.

Responsibilities for the TMF Specialist include:

• Manage TMF setup, quality management activities, reporting, metrics, and ongoing quality control/quality assurance processes.
• Ensure clinical trial documentation is complete, accurately filed, and maintained in accordance with eTMF standards, ICH-GCP guidelines, regulatory requirements, and company SOPs.
• Coordinate document collection, filing, tracking, and reporting activities across internal teams, sponsors, and external stakeholders.
• Conduct quality control reviews and approve documents to ensure inspection readiness and TMF compliance.
• Serve as a subject matter expert (SME) on TMF processes, providing guidance, training, and support to project teams and junior staff.
• Support audit and inspection readiness activities, including document retrieval, reconciliation, and records transfers.
• Monitor project timelines and deliverables to ensure commitments, deadlines, and quality standards are consistently achieved.

Required Qualifications for the TMF Specialist include:

• Bachelor's degree in a science, healthcare, or related field.
• Experience working with eTMF systems; experience with Veeva Vault and/or Trial Interactive preferred.
• Strong understanding of clinical research processes and clinical document management requirements.
• Knowledge of FDA, ICH-GCP, EMA, and other applicable regulatory requirements governing TMF management.
• Excellent organizational skills with strong attention to detail and the ability to manage multiple priorities in a fast-paced environment.
• Strong written and verbal communication skills with demonstrated ability to collaborate effectively across functional teams and external partners.
• Proficiency with Microsoft Office Suite.

Compensation for the TMF Specialist include:

• Salary Range: Competitive based on experience
• Full Benefits Package: PTO, Paid Holidays, Medical, Dental, Vision, 401K, Tuition Reimbursement, Paid Maternity Leave, Military Reserve Pay Offset

Experience Requirements:

• Level I 0-2 years of experience with TMF review and knowledge of FDA, ICH, and EMA TMF requirements.
• Level II 2-4 years of experience with TMF review and knowledge of FDA, ICH, and EMA TMF requirements.
• Level III 5+ years of experience with TMF review and knowledge of FDA, ICH, and EMA TMF requirements.

This Job opens for applications on 9/16/2026. Applications for this job will be accepted for at least 30 days from the posting date.

#LI-KP1 #LI-Hybrid

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Keywords:

TMF Specialist, Trial Master File, eTMF, Veeva Vault, Trial Interactive, Clinical Operations, Clinical Research, Clinical Documentation, TMF Management, ICH-GCP, FDA Regulations, EMA Regulations, Regulatory Compliance, Inspection Readiness, Audit Readiness, Records Management, Clinical Trials, Quality Assurance, Quality Control, Document Review, TMF Oversight, Healthcare, Biotechnology, CRO, Life Sciences, Microsoft Offic24