Praxis
11 - 50 employees
Founded 2002
🧬 Biotechnology
⚕️ Healthcare Insurance
🔬 Science
Biotechnology • Healthcare Insurance • Science
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.
TMF Operations Lead
Job not on LinkedIn
🕒 April 24
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Praxis
11 - 50 employees
Founded 2002
🧬 Biotechnology
⚕️ Healthcare Insurance
🔬 Science
Biotechnology • Healthcare Insurance • Science
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
• Be the TMF subject matter expert and trusted partner to study teams. • Oversee eTMF set-up, maintenance, and regular quality reviews. • Monitor TMF health, milestones, and deliver metrics and insights to teams. • Guide and support trial teams to stay compliant with document lists and timelines. • Identify and resolve TMF issues, escalating when needed. • Contribute to SOPs, processes, and industry best practices. • Ensure access and compliance with global TMF standards and regulations.
🎯 Requirements
• 5+ years of TMF management experience and a bachelor’s degree. • Deep knowledge of ICH/GCP, FDA, and international TMF requirements. • Strong experience with eTMF systems (Veeva preferred). • Expert understanding of TMF structure, content, and processes. • Critical thinker who can solve problems quickly and effectively. • Organized and detail oriented. • Great communicator and team player.
🏖️ Benefits
• 99% of the premium paid for medical, dental and vision plans. • Company-paid life insurance, AD&D, disability benefits, and voluntary plans. • 401(k) matching dollar-for-dollar up to 6% on eligible contributions. • Long-term stock incentives and ESPP. • Discretionary quarterly bonus. • Flexible wellness benefit. • Generous PTO and paid holidays. • Company-wide shutdowns.
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