Operational study lead for global Phase 1 oncology study (Multiple Myeloma)

Operational Study Lead (OSL) for global Phase III open label extension study (diabetic gastroparesis).

Operational Study Lead (OSL) for global Phase III open label extension study (diabetic gastroparesis).

Management and oversight of Phase III Glaucoma study (North America)

Management and oversight of Phase III Diabetic Macular Edema study (North America)

Responsible for the operational execution of Phase I and Phase III Glaucoma trials through start-up, conduct and close down

Manage and support Phase III Rheumatoid Arthritis studies (start up through close down); work cross-functionally between monitors, sites, science, data management, etc. to ensure standardization and consistency of trials in accordance with ICH/GCP guidelines and SOP’s.-Managed study start up activities (feasibility activities, site selection process, coordination and participation in investigator meetings). Reviewed and approved pre-study, initiation, monitoring and close-out visit reports to ensure GCP compliance. Performed co-monitoring visits to address site issues and outstanding action items. Identified, escalated and managed site issues including formulation and implementation of CAPA plans. Assisted with discrepancy resolution and interim analysis activities. Managed study budget, provided forecasts/accruals and oversaw payment process. Collected, reviewed and processed regulatory and study documents (reconciled in CTMS and Trial Master File). Oversaw patient transfer process (transferring active patients between study sites). Reviewed and approved informed consents/assisted with IRB submissions. Created study tools/materials (i.e. training binder, regulatory binders, site newsletters)

In-house support for clinical research studies (Phase I, II, IV/Gasteroenterology, Phase III/Anesthesiology-Pediatric)- Conducted site feasibility and selection of study sites; tracked study enrollment and screening- Liaison between clinical and data management departments to resolve data inconsistencies, queries, and to create data conventions- Managed shipment of clinical supplies (i.e. study drug, CRF’s, subject diaries)- Reviewed and reconciled regulatory documentation- Processed and tracked CRF’s and other clinical materials- Prepared and planned investigator meetings- Successfully created a system to track and generate site payments- Designed newsletters and study tools; prepared study binders- Evaluated statistical data listings and tables in search for discrepancies and outliers- Assisted with the development of CRF guidelines - Coordinated and assembled IND and NDA submissions; successfully compiled NDA submission for Phase III study within required timeframe- Compiled clinical study reports; prepared and audited appendix itemsMonitored clinical sites for Phase III Gasteroenterology study and Phase III Pediatric Anesthesiology study. - Conducted pre-study, initiation, monitoring and closeout visits. Performed general monitoring duties (i.e. regulatory binder review, drug accountability, source document verification, ensured protocol compliance and adherence to ICH/GCP)

Processed and analyzed clinical data for several Phase III Pediatric Anesthesiology studies. Performed data entry, CRF review and data review, QC checks, system validation and generated discrepancies.

Assisted study coordinators to support clinical research trials for Phase III CNS studies. Conducted phone screens, performed data entry and assisted with regulatory documentation.