Records Specialist II

Job not on LinkedIn

🔥 1 hour ago

🌐 Spain, Bulgaria, +1 more countries – Remote

🇪🇸 Spain – Remote 🇧🇬 Bulgaria – Remote 🇷🇴 Romania – Remote

⏰ Full Time

🟢 Junior

🚫👨‍🎓 No degree required

👻 Ghost score 10%

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• Just posted.
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• No salary listed.

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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 all departmental budgeted activities for assigned studies • Assist with identifying, reporting and resolving quality and efficiency concerns with records management work practices • Understand TMF Plans, TMF indexes and transition plans for assigned studies • Assist with live, web-based and/or recorded process and system training for company staff, Sponsors and/or third parties • Assist with internal and external audits and inspections globally for assigned studies • Assist with office-based and/or off-site corporate archives regionally as needed • Assist with system demonstrations, study KOMs and other targeted project team meetings globally • Assist with eTMF System Administrator responsibilities as needed • Perform additional duties assigned by the TMF Lead and/or department management

🎯 Requirements

• Successful experience and results as a Records Specialist I or equivalent in a clinical trials records management setting required • 1+ years of clinical trials records management experience required; 2+ years without degree • Experience using computerized clinical trials records management technologies required • Global clinical trials experience preferred • Knowledge of web-based communication tools for conferences and other required IT systems • Knowledge of ICH-GCP, ISO14155 and global regulations pertaining to Trial Master File management • Excellent team player, collaborative and able to work within an effective team • Ability to multitask and work effectively and independently in a fast-paced CRO environment with changing priorities • Ability to read, write, and speak fluent English • Excellent organizational and time-management skills; ability to prioritize work to meet deadlines

🏖️ Benefits

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

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