Dianthus Therapeutics - Senior Clinical Trial Associate
Requirements
• BA/BS degree or equivalent, relevant work experience. • Minimum of 5 years’ experience working on clinical studies in pharmaceutical, biotech, or CRO setting preferred. Prior CTA experience required. • Excellent interpersonal and communication skills with ability to work collaboratively across functional teams. • Strong organizational and time management skills, and strong attention to detail. • Knowledge of global regulatory and compliance requirements for clinical research. • Experience with essential documentation for Trial Master Files required. • Knowledge of drug development, clinical operation processes, medical terminology, and procedures according to FDA GCP/ICH regulatory guidelines. • Excellence with MS Office products Word, Excel, SharePoint, PowerPoint. • Experience working with clinical trial systems (CTMS, IRT, EDC) preferred.
Responsibilities
• Provides support to assigned clinical studies, taking on various responsibilities to support project and study deliverables. • Coordinates, attends and may lead study team meetings; ensures appropriate meeting scheduling and documentation, including creation, distribution and filing of meeting agendas and minutes. • Maintains and generates applicable study trackers and documents (for example: action-decision log, storyboard, patient enrollment and IRB approvals). • Monitors clinical trial insurance and license agreements across studies and work with vendors to ensure current agreements. • Supports the development and review of study documents, including study manuals. • Maintains knowledge and acts as team super-user or subject matter expert for study-related systems and processes. • Manages deliverables and navigates changing priorities. • Supports the clinical team with coordination and preparation for investigator meetings, PI calls, conferences as well as internal clinical meetings. • Supports management of the Trial Master File according to Sponsor Oversight plan to ensure accuracy and completeness. • Assists with study budget oversight, including invoice tracking, reconciliation and collaboration with cross-functional teams and vendors. • Participates in vendor selection and management meetings (e.g., CROs, IVRS, Central Labs, etc).
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