Alexandra Chakravarty's Email Addresses & Phone Numbers

📖 Summary

My extensive experience in Data Management has helped me achieve a strong background in all aspects of clinical programming and data management including: • Managing a team of clinical programmers as well as collaborating as individual contributor in the study design. • Protocol review • Database development • Creation of validation procedures, and edit checks. • Creation of SAS datasets, and data transfers. • Expertise using Medidata Rave, Oracle Clinical RDC, Infermed MACRO EDC and SAS to support Phase I-III clinical study teams.Sr. Database Programmer @ From May 2012 to Present (3 years 6 months) Novato, CAClinical Programming Team Leader (Manager) @ • Recruit, train, and have line management responsibility for 4 members of the clinical programming group, to include: o performance management / appraisals o coaching and mentoring o providing development opportunities o ensure technical and managerial training needs are identified and met o involvement in salary, bonus and incentive decisions. • Provide strategic direction and leadership of data management activities for studies • Ensure excellence within data management through the implementation and sharing of process improvements and initiatives. • Resource clinical studies appropriately within the team • Establish prioritization of tasks and ensures resolution of critical issues • Project Management responsibilities of global project where team members were located in Switzerland, UK, New Jersey and San Francisco • Project Sponsor of global initiatives From July 2009 to May 2011 (1 year 11 months) San Francisco Bay AreaLead Clinical Programmer/Sr. Clinical Database Programmer @ • Design and build databases using Oracle Clinical, Infermed MACRO EDC and Medidata Rave for the collection of patient data within the clinical database in accordance with global standards. • Database programming using Oracle Clinical, Infermed MACRO EDC and Medidata Rave, including the creation and implementation of eCRF behaviors, validation and derivation procedures and complex data logic checks (e.g. Custom Functions using C# language) • Develops, tests and reviews extraction programs, based on user requirements, for reporting and statistical analysis using SAS. • Develops and maintains custom outputs for multiple uses (e.g. medical data review, clinical study reports etc.) • Implements software programming standards (e.g. study data tabulation model - SDTM) • Undertakes training, mentoring and peer review within Clinical Database Design and Programming as required. • Identifies and proposes areas for process improvement. • Leads effective knowledge sharing on standards, procedures and issues. • Participates in / leads cross-functional working groups as functional expert. • Cooperation with local and global study teams to achieve efficient solutions. From October 2005 to May 2011 (5 years 8 months) San Francisco Bay AreaSr. Programmer Analyst @ • Design, implement, test, and document clinical research databases, and data validation programs, and relevant documentation, using Oracle Clinical software. • Disable operation of production database and data validations until successful QA and test has occurred. • Provide training and documentation to enhance end-user functionality and quality outcomes. • Coordinate specification of data transfer requirements with users, perform routine data imports and create data exports programs using SAS, Unix, SQL or PL/SQL. From June 2005 to October 2005 (5 months) Orange County, California AreaProgrammer Analyst @ • Design, implement, test, and document clinical research databases, and data validation programs, and relevant documentation, using Oracle Clinical software. • Disable operation of production database and data validations until successful QA and test has occurred. • Provide training and documentation to enhance end-user functionality and quality outcomes. • Write and maintain standard and internal operating procedures relevant to role. • Coordinate implementation and upgrade of software programs that interface with Oracle Clinical. • Coordinate specification of data transfer requirements with users, perform routine data imports and create data exports programs using SAS, Unix, SQL or PL/SQL. • Coordinate C5 Clinical Data Management technical requests, and assists in troubleshooting PC hardware and software problems. • Key role in the development of quality controlled products, including compliance of electronic systems. Monitor database integrity and system performance. • Write and test software validation plans. • Create reports requested by FDA and users using SQL, Oracle Reports or Crystal Reports. • Manipulate OC data extract views to meet statisticians or sponsors requirements. • Training support to off-site RDC users. From March 2001 to June 2005 (4 years 4 months) Cleveland/Akron, Ohio AreaAccess Database Project @ • Designed, implemented, and tested end-user forms and reports using Microsoft Access. • Designed budget and contract for project. • Wrote and maintained project documentation. From 2002 to 2003 (1 year) Cleveland/Akron, Ohio AreaInformation System Specialist Volunteer @ • Updated and entered data to the main screening receptors database. • Under direction of lead programmer, developed and modified Microsoft Access database. From 2000 to 2001 (1 year) Cleveland/Akron, Ohio AreaProgrammer Analyst (Contractor with Ford Motors, Inc.) @ • Analyzed, Developed, and Maintained end-user software using Developer Forms 4.5 / 5.0, Developer Reports 2.5 / 3.0, SQL, PL/SQL, and UNIX in the Treasury, Accounting, Purchasing, Customs and Payroll departments at Ford Motors Inc. • Debugged Basic Networking applications used by the Intranet of Ford Motors Inc. • Updated data using SQL and PL/SQL in the departments mentioned previously. • Created and updated Oracle, Access databases. • Wrote and maintained project documentation. From 1998 to 2000 (2 years) VenezuelaComputer Science @ Instituto Universitario de Tecnologia para la InformaticaComputer Engineering (Approx. 100 credits approved) @ Universidad Fermín ToroAccountancy (146 credits approved) @ Universidad Yacambu