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انتهت بتاريخ ١ أبريل ٢٠٢٦
Clinical Trial Management Associate (CTMA)
وصف الوظيفة
Akero Therapeutics, a Novo Nordisk company, is a clinical stage biopharmaceutical company focused on discovering and developing transformational treatments for patients with serious metabolic diseases marked by high unmet need. Our current focus is on advancing our lead program efruxifermin (EFX) to provide a powerful new treatment for patients with MASH (metabolic dysfunction-associated steatohepatitis). The CTMA is a key member of Clinical Operations and will closely partner with the Senior Clinical Trial Manager.
المسؤوليات
- Accountable for study level tracking as assigned by the Clinical Project Manager; e.g. monitor visit tracking and sample tracking
- Ensures patient enrollment activities are conducted in a timely manner
- Provides study level information to enable accurate and efficient supply of clinical product
- Acts as QC of Trial Master Files; creates, maintains, and closes out TMFs
- Accountable for ensuring that agendas for meetings are clear and distributed in advance
- Proactively identifies potential operational challenges
- May participate in review of data listings and preparation of interim/final clinical study reports
- Maintains internal Clinical Operations databases and document repositories
- Assist with administration of invoice reconciliation, scoping, and change orders
المؤهلات
- At least 2+ years of relevant experience and a BS or BA in a relevant scientific discipline OR At least 2+ years of relevant experience and an RN
- Must be familiar with routine medical/scientific terminology
- Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs