- Responsible for executing an optimal clinical trial supply strategy for global clinical trials, including effective risk management to supply continuity to patients- Single point of contact for the Clinical Trial Team, and responsible for clinical trial supply deliverables within Global Clinical Supply (GCS) and all other relevant associated sub-functions, maintaining quality and compliance through all activities- Leads and manages all project and local network activities and participates in cross-functional teams

- Partners with the clinical lead and local country site monitors in project execution- Provides centralized support to monitoring visits and site management for a variety of protocols, sites, and therapeutic areas- Monitors study start-up, manages resources, performs ongoing risk assessment through data trending and analytics and proposes potential mitigating actions in a timely fashion.- Leads teams of clinical analysts (CA) and clinical analyst supports (CAS)- Maintains Clinical Operation Plans- Supports development of iSite Pack templates by overseeing their preparation by clinical analysts- Closely works with site monitors and the clinical lead during study execution phase with respect to recruitment and compliance with the Clinical Operation Plan.- Perform ongoing risk assessment through data trending and analytics and proposes potential mitigating actions in a timely fashion.- Supports CRAs in management of quality issues- Reviews and approves site visit reports- Manages resourcing and transition of study team members during the execution phase.- Provides training to site monitor, clinical analysts, and clinical analyst supports- Reviews and approves investigator payments- Reviews and manages services requests received by centralized monitoring staff

- Coordinating with the regulatory affairs team towards dossier submission- Leading a team of CRAs as a local trial manager on different Phase 3a/b studies- Coordinating towards ethics committee submission- Conducting or assisting in site selection process- Undertaking site selection visits- Conducting site initiation visits- Preparing clinical trial budgets- Updating IMPACT as a local trial manager- Coordinating with headquarters and local vendors to ensure smooth supply of investigational products to investigational sites- Performing co-monitoring visits and/or quality check visits with monitors- Preparing country-level recruitment plans in coordination with monitors- Communicating with international trial managers (ITMs) and regional trial managers (RTMs) to ensure all clinical trial activities in the country are run in accordance with the clinical development plan (CDP)- Assessing recruitment/retention needs at investigational sites- Reviewing monitoring visit reports- Approving reports on IMPACTI have worked on 3 Phase 3 studies as a local trial manager, and have been part of 4 "High Compliance"-rated GCP audits, the first time ever such a rating has been given to the local affiliate in its history.

- Undertaking site selection visits- Undertaking site initiation visits- Performing routine monitoring visits in the India Regional Monitoring Group (IRMG) - South region- Coordinating with multiple investigators and investigational sites towards study conduct- Performing source data verification and other monitoring activities- Establishing subject eligibility and ensuring subjects' safety and rights are protected- Reviewing adverse events and ensuring serious adverse events are reported within the requisite timelines- Lead CRA in 2 studies- Reviewing monitoring visit reports- Mentoring junior CRAs

- Undertaking site selection visits- Undertaking site initiation visits- Performing routine monitoring visits in the India Regional Monitoring Group (IRMG) - South region- Coordinating with multiple investigators and investigational sites towards study conduct- Performing source data verification and other monitoring activities- Establishing subject eligibility and ensuring subjects' safety and rights are protected- Reviewing adverse events and ensuring serious adverse events are reported within the requisite timelines

- Working with the principal investigator towards subject recruitment- Data entry and investigational product accountability- Site master file maintenance- Ensuring adequate study supplies at the investigational site- Coordinating between the principal investigator and sponsor/CRO representatives

- Data curation- New chemical entity search- Database management