TMF Lead II

Job not on LinkedIn

🔥 15 hours ago

🌐 Argentina, United States – Remote

🇦🇷 Argentina – Remote 🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 10%

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Premier Research

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

💰 Venture Round on 2016-10

Healthcare • Consulting • Biotechnology

Premier Research is a company dedicated to helping biotech companies transform groundbreaking scientific ideas into life-changing medical treatments. They specialize in clinical research and development, product development and regulatory consulting, and offer expertise in areas such as oncology, hematology, rare diseases, cell and gene therapy, and pediatrics, among others. Premier Research is committed to boosting clinical development strategies and guiding innovations from molecule to market. They provide a range of services that support biotech firms in navigating the complex path to medical approval, with a focus on rare diseases and innovative therapies.

📋 Description

• Perform electronic and/or paper Trial Master File records management activities • Lead the set-up, maintenance and closure of TMFs, including development and ownership of study TMF Plans and indexes • Perform TMF Transitions and use Sponsor TMF processes and systems • Provide oversight, training, KPI analysis and reporting of TMF status • Identify and address TMF quality and completeness deficiencies affecting audit and inspection readiness • Act as primary TMF point of contact for project teams, Sponsors, auditors and other third parties • Work directly with records specialists assigned to studies • Work with the eTMF Administrator to resolve system-related issues • Review TMF scope of work and identify out-of-scope activities for change-order consideration • Provide regular TMF status updates to Project Leadership and Functions • Assist with monitoring security, environment and access control of Secure File Room facilities • Monitor compliance with TMF SOPs and TMF Plans • Perform live, web-based and recorded TMF process and systems training • Perform departmental budgeted activities for assigned studies • Develop, sign and maintain TMF Plans, TMF Transition Plans and indexes • Participate in TMF audits and inspections as TMF representative • Coordinate project team quality reviews of TMFs

🎯 Requirements

• Minimum of a high school diploma or international equivalent required • Undergraduate degree preferred from an accredited institution majoring in records and information management, library science, clinical, science or health related field • Equivalent level of clinical trials records management experience accepted as an alternative to the preferred undergraduate degree • 8+ years eTMF systems experience required • 8+ years of Trial Master File management experience required • 8+ years TMF Reference Model experience required • 2+ years TMF Lead experience required • Knowledge of ICH-GCP, ISO14155, FDA CFR Part 11 and global regulations related to the investigational drug and device industry required

🏖️ Benefits

• Flexibility and balance to support your life • Skills and opportunities for professional growth and career development

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