Study Design and Planning: Collaborate with cross-functional teams to design and plan BA/BE studies. This involves determining study protocols, inclusion/exclusion criteria, endpoints, and methodologies to ensure that studies are scientifically rigorous and compliant with regulatory requirements.Regulatory Compliance: Stay up-to-date with relevant regulatory guidelines and ensure that all studies are conducted in compliance with local and international regulations, such as those… Show more Study Design and Planning: Collaborate with cross-functional teams to design and plan BA/BE studies. This involves determining study protocols, inclusion/exclusion criteria, endpoints, and methodologies to ensure that studies are scientifically rigorous and compliant with regulatory requirements.Regulatory Compliance: Stay up-to-date with relevant regulatory guidelines and ensure that all studies are conducted in compliance with local and international regulations, such as those outlined by the FDA (Food and Drug Administration) and other regulatory bodies.Study Implementation: Oversee the execution of BA/BE studies, including site selection, contract negotiations, and site initiation. Coordinate with clinical research organizations (CROs), study sites, and investigators to ensure smooth study implementation.Project Management: Manage study timelines, budgets, and resources effectively to ensure that studies are completed on schedule and within budget constraints. This involves monitoring study progress, identifying potential issues, and implementing corrective actions as needed.Team Management: Lead and manage a team of clinical operations professionals, including clinical project managers, study coordinators, and other staff members. Provide guidance, mentoring, and support to ensure that the team works cohesively and efficiently. Show less

Clinical Research Associate