Vienna, Vienna, Austria
Lifecycle of vaccine clinical trials, ensuring adherence to GCP and regulatory requirements, managing budgets and timelines, and overseeing service providers. Key responsibilities include managing study start-up to closeout phases, tracking milestones and deliverables, ensuring data quality through metric review, collaborating on financial agreements, and participating in quality assurance activities.
Preparation for an In Vitro Fertility Clinical Trial: Protocol development, drafting informed consent forms, conducting feasibility studies and identifying suitable clinical trial sites, ensuring regulatory compliance and streamlining trial setup processes.
Direction for the operations, management, utilization, risk management, and quality improvement within the assigned clinical trials, and applies management theory and concepts to leading, staffing, monitoring, evaluating, and data gathering including the development of relevant outcome measures pertinent to the clinical studies Accountable for efficient, effective utilization of approved physical, financial, and human resources; guiding and coordinating activities of the clinical trials in accordance with professional standards; supporting the goals and strategic direction
Leading all phases of project management activities in clinical trials. Set and fulfill customer expectations throughout the entire project as primary point of contact for the Customer. Monitor study timelines and manage the financial components including budgets, revenue forecasting and change orders. Identifying potential study risks and mitigation strategies, managing escalations.
Responsible to maintain control of clinical operations activities including Feasibility, Site Activation, Regulatory Maintenance, Clinical Monitoring, Site and Study File Management to ensure quality and timely performance of all investigational site activities for clinical studies conducted by Allucent in Czech Republic, Hungary, Moldova, Romania and Slovakia.
QA - Auditing, Preparation for 4 FDA inspections = 4 NAI, Feasibilities, Preparation for RA/EC submission, Regulatory reporting, Proof of Concept, Evaluation of Technology, Health Economy Assessment, Clinical Monitoring, Protocol Design