TMF Operations Lead

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $99k - $119k / year

⏰ Full Time

🟠 Senior

⚙️ Operations

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Praxis

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2002

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Praxis is a company dedicated to connecting patients with meaningful clinical trial opportunities. With a focus on creating customized recruitment programs, Praxis utilizes a variety of specialized tools and extensive experience across various therapeutic areas to ensure they reach the right patients worldwide. Established in 2002, the company emphasizes the importance of patient engagement and utilizes sophisticated data insights to enhance the patient journey in clinical research.

📋 Description

• Serve as the TMF subject matter expert and trusted partner to study teams, providing guidance on TMF requirements, expectations, and best practices throughout the clinical trial lifecycle • Lead the setup, maintenance, quality review, and closeout of electronic Trial Master Files • Monitor TMF health, completeness, timeliness, and quality against study milestones • Translate TMF metrics and trends into insights, risks, and recommended actions for study teams and leadership • Partner with Clinical Operations, external vendors, and cross-functional stakeholders to maintain expected document lists and resolve documentation gaps • Identify, investigate, and drive resolution of missing, late, or poor-quality documentation • Escalate significant TMF risks with appropriate urgency and clear ownership • Support inspection readiness activities, audits, and regulatory inspections • Contribute to continuous improvement of TMF procedures, work instructions, training, systems, and operating practices

🎯 Requirements

• Bachelor’s degree in life sciences, healthcare, or a related field • At least 5 years of progressive experience in TMF operations or TMF management within biotechnology, pharmaceutical, or clinical research • Deep working knowledge of ICH-GCP, FDA requirements, and applicable global regulations and guidance • Strong experience with electronic TMF platforms • Expert understanding of TMF structure, content, lifecycle management, quality controls, and inspection-readiness expectations • Ability to assess TMF health, interpret metrics, identify risks, and drive issues through resolution • Ability to operate autonomously, identify emerging risks, and take ownership of outcomes • Collaborative, curious, and improvement-oriented mindset • Willingness to challenge assumptions and improve ways of working • Comfort with regular computer and office equipment use, screen work, basic hand coordination, sustained focus, clear communication, and occasional movement • Reasonable accommodations may be made for individuals with disabilities • Experience with Veeva Vault eTMF is strongly preferred

🏖️ Benefits

• Remote work arrangement • Equal opportunity employer committed to diversity, equity, and inclusion