I am a senior clinical operations professional with 10 years of experience supporting Phase I-IV clinical studies across CRO and sponsor-facing environments. I have worked as a Clinical Research Associate, Senior CRA, Clinical Trial Manager, and Clinical Team Manager for organizations including Syneos Health, Thermo Fisher Scientific, Worldwide Clinical Trials, Altiora CRO, and independent consulting engagements.
I manage the full clinical trial lifecycle, from site feasibility and start-up through regulatory submissions, site activation, monitoring, close-out, database lock, and inspection readiness. My experience includes both onsite and remote monitoring, site qualification, initiation, interim monitoring, source document review, data query resolution, and investigational product accountability.
I lead clinical operations teams and collaborate closely with project managers, sponsors, vendors, investigators, and site personnel. I am experienced in monitoring strategy development, clinical resource planning, budget and timeline management, CRA training, quality systems, and the preparation of clinical monitoring plans and guidance.
I have supported studies in multiple therapeutic areas, including oncology, cardiovascular disease, neurology, psychiatry, respiratory diseases, rare diseases, ophthalmology, nephrology, and biologics and biosimilars. I have contributed to successful site activations, recruitment performance, sponsor audits, regulatory inspections, and contingency planning for studies in complex environments such as Ukraine and Israel.
I am a motivated, results-oriented professional with strong leadership, communication, problem-solving, and stakeholder-management skills. I value an inclusive and respectful workplace culture and focus on building productive, lasting relationships with colleagues, clients, CROs, sponsors, and clinical sites.