Alentis Therapeutics

Clinical Research

• Act as the primary Clinical Operations and/or Clinical Science lead and the face of Alentis towards external vendors, CROs, investigators, and study partners
• Lead and oversee the preparation, execution, and delivery of complex global clinical trials
• Provide strategic leadership and operational oversight for one or more clinical studies and support cross-study alignment across development programs
• Coordinate the development, review, and approval of study documents, including protocols, ICFs, guidelines, regulatory documents, monitoring plans, data management plans, statistical analysis plans, and clinical study reports
• Contribute to regulatory submissions and responses to Health Authorities, ECs/IRBs, DSMBs, and other regulatory bodies
• Contribute to safety data monitoring and signal finding with clinical development physicians
• Oversee forecasting and planning of IMP, ancillary supplies, and study materials
• Review feasibility assessments, contribute to vendor selection and contract negotiations, and oversee vendors
• Plan and lead Investigator Meetings, vendor meetings, and study-specific training
• Ensure delivery of studies within planned timelines, quality expectations, and approved budgets
• Oversee monitoring activities and review study performance metrics for data integrity, protocol compliance, and patient safety
• Identify operational risks, develop mitigation plans, and escalate critical issues
• Support inspection readiness, audits, inspections, and CAPA management
• Ensure study documentation is inspection-ready and archived within the (e)TMF
• Oversee database lock, study close-out, and study reporting activities
• Provide Clinical Science and/or Operations input into the Clinical Development Plan and broader program planning
• Drive continuous improvement and contribute to clinical processes, standards, and SOPs
• Mentor Clinical Trial Leads, Clinical Trial Managers, and cross-functional study team members
• Maintain appropriate training and compliance with regulations, GCP, and company procedures

Explore Senior Clinical Trial Leader – Oncology at Alentis Therapeutics. Review requirements and application details.

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Senior Clinical Trial Leader – Oncology