Document Specialist – UK/Romania

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AIXIAL GROUP

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

AIXIAL GROUP is a leading Clinical Research Organization (CRO) committed to delivering efficient clinical trials. They offer full-service clinical trials, functional service provision, and consulting support for clinical development. Their areas of expertise include oncology, radiopharmaceuticals, cell and gene therapy, rare diseases, and real-world evidence. AIXIAL GROUP focuses on applying advanced technology for clinical data management and offers solutions from the early phase to phase II/III CRO services, including decentralized trials. They cater to the needs of biotech and pharma companies worldwide, offering expertise in specialized therapeutic areas to ensure successful clinical trials.

📋 Description

• TMF Operations responsibilities including planning, processes, systems, and training • Accountable for management of assigned TMF Operations tasks, including Trial Master File documentation • Deliver eTMF services to contractual and compliance expectations • Maintain the assigned eTMFs in an audit-ready state • Administers eTMF user training and access • Conduct periodic quality reviews of TMFs and report findings • Work independently on specific TMFs or associated tasks • Provide training, mentoring, coaching for assigned TMFs

🎯 Requirements

• Proficient in MS Office (particularly MS Word and MS Excel) • Technically-oriented with ability to learn various associated systems • Experience working in the clinical trial industry • Experience within TMF Operations in clinical trial industry • Experience with Veeva Vault and eTMF • A science or health related university degree would be highly advantageous • Experience working in a document management environment (e.g. archive, library) • Fluent in spoken and written English

🏖️ Benefits

• Fully remote • Professional development opportunities