• Successfully led country study start-ups in late-stage multicenter international trials in various therapeutic areas (COVID-19, Vaccines, Oncology).•Concurrently managed ongoing country-level operational activities at 6-8 assigned trials.•Acted as a Subject Matter Expert for Essential Documents and Clinical Study Agreements.•Demonstrated a solid track record of providing strategic contribution in cross-functional process improvement initiatives, resulting in acknowledgment through multiple corporate awards.

Worked as a FSP for Merck

•As a Local Study Lead, coordinated all aspects of study conduct at the country level from feasibility to close-out phase at international phase III trials (COPD, asthma). Organized regulatory and ethics submissions, import of supplies, set up of country budgets, oversight of contracts execution, and coordinated the CRAs' team. •Coached the Local Study Team, reviewed monitoring reports, planned and controlled key study metrics with CRM support, and maintained ongoing collaboration with the Global Study team and vendors to ensure timely achievement of study start-up, recruitment, interim analysis/DBLs, and other critical study and compliance targets.

•Effectively conducted a wide range of site management and monitoring activities for 10+ dedicated sites in various therapeutic areas; demonstrated consistent compliance with key quality metrics and study milestones.

• Effectively performed site management and conducted all types of monitoring visits in 10+ sites within international phase III clinical trials (Respiratory, Ophthalmology, CNS) to ensure compliance with ICH GCP and study protocols. • Provided support to the regulatory department in preparation of regulatory and ethics submission packages, including import/export license and safety submissions.