Hema Mani

adc4hz@r.postjobfree.com +91-968*******

Professional Summary

Over 15 years of professional experience in IT with hands on technical expertise in various domains of software industry including 11 years of experience working in Biopharmaceutical industry.

Strong expertise in the entire phase of clinical trials that includes Analyzing, Designing, Development, Testing, Implementation, Maintenance, Production Support, Migration of clinical database.

Specialist in CDMS like Medidata RAVE (4.2 to 5.6, 2014, 2018 versions), Medrio, Merge eClinical OS, Inform.

Experience in clinical database setup and programming experience for several studies and several Clients.

Hands-on experience in developing Edit Checks, Custom Functions, Custom Data Extracts, Custom Integrations and Custom Reporting development on Medidata RAVE EDC systems.

Expertise in Amendment Manager – study migrations and Rave safety gateway process.

Domain Expertise in Pharmaceutical, Health Care, Clinical Data Management, Retail.

Good Knowledge of ICH GCP, 21 CFR Part 11, SDTM, CDISC.

Excellent Team leading, presentation and interpersonal skills with a strong desire to achieve specified goals.

Dynamic team player with ability to work with all levels in an organization.

Therapeutic Experience:

Phase I/II/III/IV – HCV, HBV, Oncology, HIV, RESP, CVS

Educational Qualification

Master of Computer Applications (M.C.A)

Bachelor of Sciences

Trainings and Certifications

Medidata RAVE Certified Study Builder from Medidata Solutions – July 2018.

Medidata RAVE Certified Study Administrator from Medidata Solutions – Sep 2018.

Technical Skills

Clinical Database

Medidata RAVE 4.x/5.x, 2014.1.0, 2018, Medrio, Merge, Inform

RDBMS

SQL Server 2008/2005, My SQL, MS Access, Oracle 8i

Application Tools

Visual Studio.Net, VB, C# .Net, SSAS, SSIS, DTS Import/Export Packages

ETL Tools

Erwin, Informatica, Data Stage

Tools & Utilities

SQL Server Management Studio, SQL Business Intelligence Studio, Enterprise Manager, SQL Trace, SQL Profiler, Query Analyzer, BCP, SQL DBCompare,

Reporting Tools

SQL Server Reporting Services, Crystal Report, Business Objects XI, JReview

Operating Systems

Windows 7,9x/2000/NT

Other Tools

MS Visio, Enterprise Architect, Visual Source Safe

Professional Experience

Gilead Sciences, Foster City, CA, USA Jan 2016 to Till Date

Sr. EDC Programmer

Managing all the new study builds across all therapeutic areas and resource allocation both internal and external vendors.

Worked in the Project Management capacity to lead both internal and vendor study team meetings for review and status updates throughout study build process and interact with vendors to communicate expectations for study timelines and milestones are met and deliverables are of high quality.

Proactively identify potential risk and provide risk mitigation strategies during the study build process.

As a subject matter expert – providing technical EDC support to internal study teams on all programming related activities.

Involved in iMedidata roll out strategy and planning.

Lead the Core configuration review and update project with the internal team members.

Worked on multiple studies to update the database based on GDPR update processes.

Worked on Global library implementation and Rave Safety Gateway processes.

Responsible for design, development, testing, maintenance and migration of clinical databases.

Responsible for issue investigation in production database.

Responsible for the training, mentoring, and growth of new team members.

Involved in process improvements and best practices implementation.

Environment: Medidata Rave 2014, 2018 Platform, SQL Server, Visual Studio C#.NET, Win 7/ NT.

Wincere Inc., Santa Clara, CA, USA Aug 2011 to Jan 2016

Programmer Analyst

Worked with multiple Clients - Gilead Sciences, Onyx Pharmaceuticals, Edward Lifesciences, Bayer, Biomarin.

Develop and maintain a close liaison with Client/Sponsor, core team members, Project Managers, Data Manager / Bio-Statistician to ensure the timelines are met for successful project delivery.

Lead both internal and client-facing study team meetings for review and status updates through study startup and Post Go-Live.

Manage project and the resources necessary for their successful execution.

Worked on Phase I/II/III/IV - Oncology, HIV, RESP, HCV/HBV, CVS Clinical Trials.

Therapeutic Area Lead for all Liver Disease (HCV, HBV, Liver Fibrosis) studies at Gilead Sciences.

Reviewed study-specific protocols and design Case Report Forms (eCRFs) for potential data collection.

Prepared annotated eCRFs and unique eCRFs

Responsible for creating eCRF specifications and Data Validation specifications through the life cycle of a trial.

Programmed Edit Checks and Custom Functions in Medidata Rave.

Extracted Clinical data from RAVE EDC System for the SAS Custom Data Extract process.

Responsible for design, development, testing, maintenance and migration of clinical databases for assigned studies.

Responsible for the training, mentoring, and growth of new team members.

Involved in process improvements and best practices implementation.

Environment: Medidata Rave 5.x,2014 Platform, SQL Server, Visual Studio C#.NET, Win 7/ NT.

Transnative Associates Inc, Santa Clara, CA, USA Dec 2010 to Aug 2011

Management Analyst / Technical Services

Design systems and procedures, conduct process simplifications and measurement studies, and prepare technical operations and procedures manuals for various IT related projects to assist management in feasibility study and effective decision making for each project.

Responsible for providing software development & project management services to various clients in all areas.

Analyze data, gather and develop solutions for successful functioning of newly implemented systems or procedures.

Responsible for determining the technical requirement of each software development project, interact with clients, develop a strategy to execute the projects in consultation with the management as well as the clients.

Environment: SQL Server 2008/2005 Data warehouse / Business Intelligence Studio, Visual Studio .NET, C/C#, Oracle, Unix/Linux, ETL, T-SQL, MS Excel, MS Access, UML.

Transnative Associates Inc, Santa Clara, CA, USA Aug 2009 – Nov 2010

Programmer Analyst

Worked closely with the client in understanding their data processing and business requirements in providing highly available technical solutions.

Involved in the development of Star and Snowflake to model the data warehouse.

Designed database, database objects and SPE data warehouse effectively considering the facts and dimensions.

Migrated OLTP data from text files, Excel, Chemstation to SQL Server OLAP databases (staging database) using SSIS and then Transformed the Staging data in to the SPE data warehouse.

Extensively worked on ETL and data integration in developing ETL mappings and scripts using SSIS.

Scheduled Jobs in SQL server agent to automate the SSIS packages executions.

Wrote complex T-SQL queries and Stored Procedures to transform the data and load to the Fact tables.

Implemented Slowly Changing Dimensions (SCD) to maintain historical data in various data marts.

Configured and maintained Report Manager and Report Server for SSRS.

Created Cross-Tab, Drill-down, Sub-Report, Customized and Ad-hoc reports using SSRS.

Identified and worked with Parameters and fetched data using complex MDX expressions for generating parameterized OLAP reports in SSRS.

Performed unit testing and system testing.

Environment: SQL Server 2008/2005, Business Intelligence Studio, SQL Server 2008/2005, SQL Reporting Services, SQL Integration Services, T-SQL, Visual Studio .NET, MDX, Erwin, MS Excel, MS Access, UML, SQL Server Analysis Server.

Prithvi Information Solutions Ltd, India Oct 2007 – Dec 2008

Sr. Software Engineer

Involved in high level design document by interacting with the client for the understanding of the raw business requirements and translating them for designing technical requirements.

Designed database and table variables effectively and impact analysis on the existing schema.

Implemented Changed Data Capture (CDC) by using parameter files and CDC table.

Experience in using dynamic management views (DMV) and dynamic management functions (DMF) for finding out long running queries.

Created Re-Usable Components – Data Export Utility SQL script which extracts the data from the database and generate the required file format, the extracted files then transferred to the FTP Server.

Migrated data from text files and Excel to SQL Server databases using SSIS.

Implemented new T-SQL features added in SQL Server 2005 that are Data partitioning, Error handling through TRY-CATCH statement, Common Table Expression (CTE).

Migration of the database objects from MySQL and Oracle DB to SQL Server 2005 using SSMA (Migration Assistant).

Configured and maintained Report Manager and Report Server SSRS.

Identified and added the report parameters and created the reports based on the requirements using SSRS 2005.

Actively supported business users for changes in reports as and when required.

Analyzed reports and fixed bugs in stored procedures.

Used complex expressions to group data, filter and parameterize reports.

Coding Stored Procedures, Views, Indexes and Functions and implementing the business logic.

Generated alerts using the Notification Services 2005 by sending emails.

Performed unit testing on different modules and Trouble shooting and query optimization.

Environment: SQL Server 2005, SQL Integration Services, SQL Reporting Services, SSMA (Migration Assistant), SQL Server 2005, Business Intelligence Studio, T-SQL, Visual Studio .NET, SQL Server Notification Services, Crystal Reports, SQL Profiler, MS Excel, MS Access.

Ecentric Solutions Pvt Ltd (Paradigm Infotech), India

Sr. Software Engineer - Medidata Rave May 2005 – Sep 2007

Performed various activities for Medidata Solutions as a partner to eCentric solutions for study build, edit check implementation and custom function programming and testing.

Worked on complex edit checks and custom functions.

Implementing the custom functions business logic through Stored Procedures and T-SQL Queries in SQL Server and mapping the business logic code to the web application.

Fixing the Production Issues relating to the database queries and performance

Coding Stored Procedures, Views, Indexes and Queries.

Trouble shooting and query optimization.

Performed Unit testing of the Rave after implementing the logic.

Environment: Medidata Rave 4.x/5.x Platform, SQL Server 2000/2005, TSQL, Visual Studio .NET 2005, Win XP/2000 Server.

Powergence Technologies, India Sep 2003 – May 2005

Software Engineer

Designing and developing the SCA Planner database. Involved in populating with different flat files and applying various business rules per the clients requirements.

Involved in the technical design documentation of the SCA Planner data warehouse schema by interacting with the client.

Supported business analysts, end-users for data validation by providing them with SQL queries tailored to meet their business requirements. Also validated the data by working with the reporting team.

Migrated data from legacy files to SQL Server databases using SSIS.

Configured and maintained Report Manager and Report Server SSRS for different modules.

Identified and added the report parameters and created the drill down reports based on the requirements using SSRS.

Migration of the mappings from dev to test, test to load-test, load-test to pre-prod and from pre-prod to prod environments.

Provided support to end-users for all data/performance issues in Production environment.

Environment: SQL Server 2000, DTS, SQL Server Analysis Server, SQL Reporting Services, T-SQL, Win 2000 Server.

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