The Senior Specialist, Clinical Trial Associate provides clinical study and Trial Master File (TMF) support for clinical operations. This involves supporting Clinical Trial Managers (CTMs) with activities related to: study start-up; investigator site feasibility and selection; essential document review related to investigator site initiation and investigational product release and patient enrollment. This position may also provide support in project team meetings by capturing meeting minutes/action items and following up with action item owners to ensure tasks are completed. The incumbent is also responsible for contributing to study budget management. This includes the review of vendor invoices for accuracy against budget, tracking vendor payments. The incumbent works cross-functionally with internal departments and external resources on Clinical Development related issues. The Senior Specialist, Clinical Trial Associate supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. Primary duties/responsibilities include facilitating clinical document management activities such as ensuring proper application of regulatory requirements, ensuring electronic trial master files (eTMF) compliance, responding to TMF-related inquiries, performing quality checks of TMF-related documents, applying ICH guidelines to generate filing indices, maintaining correspondence lists, contributing to health authority inspection readiness, and liaising with Contract Research Organizations (CROs). Supports CTMs with study start-up, site feasibility and selection, document review, and patient enrollment. Assists CTMs with oversight of CROs and other vendors, prepares and manages clinical documents and presentations, manages clinical study conduct binders, reviews vendor invoices for accuracy against budget, and performs other tasks as assigned. Requires a bachelor's degree in a relevant life science or healthcare-related discipline and minimum 4 years of clinical research support experience in pharmaceutical, biotechnology, or related environment. Knowledge of GCP, ICH guidelines, proficiency with Microsoft Word and Excel, excellent communication skills, ability to work independently and collaboratively, analytical thinking, and excellent planning and organizational skills are required. Preferred experience includes TMF management, CRO interaction, TMF QC, and Microsoft PowerPoint. Travel requirement is 10%. This is an office-based position.
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