Head of Study design and Custom function programming. Responsible for Study designs, Implementation, migrations and upgrades of RAVE databases. Subject matter expert for Study design, and Custom function programming.Projects:• Head of Study design and programming function• Leading study builds\migrations• Design and implementation of clinical trials• Quality Oversight• Collaboration with Vendors and FSP

As a lead clinical programmer at this CRO worked for multiple clients for Study builds and Custom function programming. Mentored my direct reports as well as new programmers in the organization. SME in custom function programing and RAVE study design. Designed studies with re-usable components and adaptive design methods. Projects:• Clinical Programming in EDC system RAVE• eCRF design, Study design, study build, Programming, Migrations• Building complex custom functions for EDC system RAVE• Design and development of complex oncology studies.• Subject matter expert in Custom functions and study designs concepts• MCTMS integrations• IXRS integrations• Standardization of Custom Function checks• RAVE administration• Vendor data imports and validation using SAS import programs• • Trouble shooting for performance related issues with the system.• Training, mentoring new programmers.• Project planning, resource planning for study deliverable timelines

Client: Amgen, Thousand Oaks, CA • Clinical Programming in EDC system RAAVE• Building custom functions for EDC system RAVE• Study build, Programming, Migrations• Standardization of Custom Function checks• Building oncology studies• Oncology RECIST1.1, irRC checks standardization• Collaboration with the Data Management team to help build the DMP (Data Management Plan)Client: Ludwig Institute for Cancer Research Ltd. New York NY • Working as a consultant to build Oncology eCRFs.• Developed custom function checks for RECIST1.1.• Developed custom function checks for iRrc.Client: PAXVAX Corporation – California• Developed custom functions for Cholera Vaccine study• Mentoring Study designers in eCRF design based on the protocol of the study.

• Study Design, build, Edit check Programming, Migrations• Standardization of Custom Function checks and building Standard Study.• Process development for EDC programming• Working/managing offshore programmers.• Training and Mentoring new programmers