Lead a talented Clinical Study Team with associates from diverse functions including Physicians, Scientists, CRAs, CTMs and associates from other functions to implement and manage Phase 3 studies from Clinical Study Blueprint (CSB) to sNDA submission for Major Depressive Disorder indication. We do this in cross-functional collaboration across entire life cycle of the study including site selection, site initiation, budget preparation and management, study implementation, vendor selection and management, enrollment management, safety management, DB lock, CSR, sNDA submission, inspection readiness, and audit supports.

As an Operational Study Lead, lead a talented diverse group of Clinical Trial Team including Physicians, Scientists, CRAs, CTMs and associates from other functions to implement and manage Phase 3 studies from Clinical Study Blueprint (CSB) to sNDA submission for Bipolar indication. Lead the cross-functional team to manage the entire life cycle of the studies from site selection, site initiation, budget management, study implementation, vendor selection and management, enrollment management, safety management, DB lock, CSR, sNDA submission, inspection readiness, and audit supports. Lead the weekly clinical trial team meeting to address day to day issues, make necessary decisions, and manage all aspects of the studies.

As part of the Clinical Development team perform in all study activities including clinical data review, raising clinical queries in EDC, recruitment management, ICF development, and providing protocol training to sites to boost recruitment. In addition, led the vendor team and managed the CRO and vendor services (PPD, ECG, Central lab, rater services, Spirometry etc.) for the phase 4 Chronic Obstructive Pulmonary Disease (COPD) study. Led the e-diary (AM3) review with study team to identify possible unreported moderate and severe COPD events. One major issue the study experienced was that sites were not reporting all COPD exacerbations. I have developed an easy technique to identify exacerbations from eDiary (AM3) data and shared with the study team to identify missing prominent exacerbations.

Lead data management activities including study startup activities for the phase 3 psychiatric studies. Ensure optimum data collection, data cleaning (creating and resolving queries in EDC), reviewing clinical data, SAE reconciliation, and providing clean data to study team. Successfully managed and locked three phase 3 studies that led to approval of drug for Schizophrenia.

Manage the data management activities of phase III oncology studies with CROs that led to approval of a drug for Breast Cancer. Oversee entire data management from study start up to database lock. Review data listings and patient profiles for scientific content and data validation. Ensure data collection meets protocol requirements as well as GCP & ICH guidelines. Author and approve various data management documents.

Supervise the CROs that performed data management activities for 4 outsourced studies in Infectious Disease TA. Review data listings including adverse events, safety listings, and microbiology listings. Author and approve number of data management related documents including, data management plan, edit check, DC data entry guidelines, vendor data reconciliation plans etc. Provide clinical data timely to sponsors to support the business needs.

Manage the data management activities of phase 3 studies that led to the FDA approval for Crohn’s disease. Overview and approve data management related documents such as data validation specification, edit checks, data entry & data handling convention, reconciliation plan, data review plan, and data management plan. Review data listings, tables, and patient profiles.