ETMF CONSULTANT

About the role

The eTMF Consultant is responsible for the review, management, and quality oversight of clinical trial documentation within the Electronic Trial Master File (eTMF). This role ensures that all trial documents are complete, accurate, compliant with regulatory requirements, and maintained in a state of continuous inspection readiness. The ideal candidate is highly organized, detail-oriented, and capable of managing large volumes of documentation while delivering results in a fast-paced clinical research environment. This role is critical to ensuring clinical trial documentation remains complete, compliant, and inspection-ready throughout the study lifecycle while supporting successful regulatory inspections and audits. Location: remote, Massachusetts. Employment type: Contract. Worksite: On‑Site.

Responsibilities

• Review and maintain clinical trial documentation within the eTMF to ensure quality, accuracy, and completeness.
• Perform ongoing quality control reviews to identify and resolve document filing, metadata, and compliance issues.
• Ensure Trial Master Files comply with applicable regulatory requirements, sponsor expectations, and industry standards.
• Monitor eTMF health metrics and proactively address gaps, missing documents, and overdue filings.
• Support inspection and audit readiness by maintaining complete and accurate documentation throughout the study lifecycle.
• Collaborate with Clinical Operations, Study Management, CROs, and functional teams to ensure timely document collection and filing.
• Provide guidance and recommendations on eTMF best practices and process improvements.
• Participate in TMF reconciliation activities and support study start-up, maintenance, and closeout activities.
• Generate reports and communicate documentation status, risks, and remediation plans to stakeholders.
• Contribute to the development and enhancement of TMF procedures, training materials, and quality processes.

Qualifications

• Bachelor’s degree in Life Sciences, Healthcare, or a related field, or equivalent experience.
• Experience managing and reviewing clinical trial documentation within an eTMF environment.
• Strong understanding of ICH-GCP guidelines, TMF Reference Model, and regulatory requirements.
• Experience supporting audit and inspection readiness activities.
• Proficiency with leading eTMF systems and document management platforms.
• Excellent attention to detail and organizational skills.
• Strong communication and stakeholder management abilities.
• Experience working with sponsors, CROs, or pharmaceutical/biotechnology companies.
• Knowledge of TMF metrics, inspection readiness strategies, and quality management processes.
• Experience supporting global clinical trials across multiple therapeutic areas.

Skills

• Results-driven with a strong focus on quality and compliance.
• Ability to work effectively in a high-volume, deadline-driven environment.
• Strong analytical and problem-solving skills.
• Excellent time management and prioritization capabilities.
• Ability to work independently while collaborating across multiple functional teams.
• Continuous improvement mindset with a focus on operational efficiency.