Atrium Therapeutics

Clinical Research

• Accountable for overall clinical study operations, including CRO and vendor management, project plans, budgets, and resource management
• Lead development of study operational plans and contribute to functional area plans and processes
• Oversee CROs, vendors, and sites while ensuring GCP and regulatory compliance
• Represent clinical operations in cross-functional teams
• Develop and manage study timelines and budgets with the Clinical Operations Lead, internal leadership, and CROs
• Manage clinical study vendors and establish deliverables and KPIs
• Develop study-specific training for site staff, CRAs, and vendors and present at Investigator and Kick-off meetings
• Oversee submissions and approvals to Competent Authorities and IRB/Ethics Committees
• Develop clinical monitoring strategies to meet timelines and ensure quality deliverables
• Manage and oversee eTMF structure, plans, and quality
• Manage investigator selection, drug supply projections, study start-up, recruitment and retention, data collection, database locks, drug accountability, and study closeout
• Contribute to clinical trial outlines, protocols, informed consent forms, and clinical study reports
• Lead or collaborate on project plans, training, system builds, CRF designs, and UATs
• Identify and resolve issues and risks with cross-functional teams and service providers
• Collaborate with data management and CRAs to ensure data quality and cleaning timelines
• Perform clinical data review, including query generation, as needed
• Contribute to process improvements, initiatives, and SOPs
• Provide direction and mentoring to junior team members
• Escalate CRA performance and site compliance issues
• May have line management responsibilities

Explore Senior Clinical Trial Manager at Atrium Therapeutics. Review requirements and application details.