SUMMARY

• Over 14 + years of experience in Clinical Programming and Clinical Data Management which includes end to end programming activities in Clinical Data Management Life Cycle (RAVE, SDTM, SQL, Base SAS, OpenCDISC (Pinnacle 21 Enterprise), I - Review and Final database locks).
• Handled end to end operations for Clinical Database programming - Medidata RAVE, INFORM, OC/OCRDC, CDASH, SDTM/CDISC conversions.
• Hands on experience on various components of SDTM submission packages (SDTM Conversion, CRF Annotations, SDRG and Define.XML) for multiple clients
• Managed the teams of clinical programmers (CDISC/SDTM) programmers and always ensured complete, accurate and timely deliverables for spectrum of Pharmaceutical firms across the globe
• An effective project manager who can independently handle projects starting from very initiation RFP to closure.
• Good understanding on ICH-GCP, 21CFR Part 11 and knowledge in writing clinical processes in compliance with regulatory guidelines.
• Expertise in Migration projects between different database systems for pharma clients.
• SME & Training Lead for Medidata RAVE for over 9+ years and have managed multiple study builds and programming maintenance activities across therapeutic areas. As a trainer I have trained 80+ programmers globally.
• CDISC certification in “SDTM Theory and Applications”. SME & training Lead for CDISC(SDTM)
• Plan and coordinate database design and SDTM development. Acting as an SME/Consultant for SDTM, RAVE (Medidata) and OpenCDISC (Pinnacle 21 Enterprise) applications, providing training on these platforms and resolve the critical issues

PROFESSIONAL EXPERIENCE

Confidential

SME and Global Data Manager

Responsibilities:

• Medidata (RAVE) Expert: SME & trainer for RAVE
• Project management, People management, Resource management, Recruitment, Training and development.
• Developing Clinical Study databases and database programming tasks. (Forms design(eCRFs), Edit Checks programming, Custom Functions programming) using Rave, C#, .NET, HTMLS, CSS and SQL/PLSQL, SAS, ADaM.
• Built various Data Management reports using BOXI/BO4.
• Involved in Global Library implementation based on GL standards.
• Performing Amendment/Migration for mid-study changes and provide the Impact Analysis on Data Management for continuation of Study conduct.
• Proficient in Clinical Trial Management System (CTMS) integration, Medical Coding setup, Targeted Source Data Review (TSDV) setup, Grants Manager, Balance, Patient Cloud application
• Interactive Web Response System (IWRS)integration setup between Medidata RAVE database and external IWRS systems for randomized studies.
• Assisting on all Medidata Cloud Application technical aspect related with Clinical Data Management.
• Accountable for ensuring submission data sets confirm to the data standards expected by regulatory agencies, including traceability from data collection to submission data sets.
• Playing an advisory role and Interacting with vendors
• Critical review of eCRF designs to ensure compatibility/conformance with CDASH/SDTM standards
• Responsible for maintaining Coder, ‘Medidata application as part Study Group Owner team.
• Assisting core CDM team members with support on various specification preparations.
• Import, export and manipulate data using SQL. Report and analyse clinical data using SQL server reporting services (SSRS) and SQL server analytic level services (SSAS).
• Mentoring and supporting junior clinical team members
• Proactively identify issues and contribute to solutions.
• Ensure quality for internal and external deliverable
• Adhere to development best practices including test driven development
• Coordination and monitoring CRO assigned tasks.

Confidential

Associate Manager

Responsibilities:

• Project management, People management, Resource management, Recruitment, Training and development.
• Planning and execution of clinical trials ensuring quality, timelines within budgets.
• Mentor other team members and Lead Programmers in training and developing technical and/or database expertise.
• Independently bring project solutions to the CDP teams and the Clinical Data Programming department.
• Meet objectives as assigned, and interact with the project team to organize timelines, responsibilities and deliverables.
• Playing an advisory role and Interacting with vendors
• Accountable for ensuring submission data sets confirm to the data standards expected by regulatory agencies, including traceability from data collection to submission data sets.
• Critical review of eCRF designs to ensure compatibility/conformance with CDASH/SDTM standards
• Responsible for maintaining Coder, iMedidata application as part Study Group Owner team.
• Assisting core CDM team members with support on various specification preparations.
• Involving in Global Library implementation based on GL standards.
• Performing Amendment/Migration for mid-study changes and provides the Impact Analysis on Data Management for continuation of Study conduct.
• Assisting on all Medidata Cloud Application technical aspect related with Clinical Data Management.
• Assist in Developing Clinical Study Build (eCRFs, Edit Checks, Custom Functions) using Rave.
• Built various Data Management reports using BOXI/BO4.
• Good knowledge on CTMS, Grants Manager, Balance, Patient Cloud application.
• Served as consultant for CDISC(SDTM) across clinical programming division.
• Author mapping specification from source (raw) data to target CDISC(SDTM) and/or sponsor defined standards)
• Create annotated (aCRF), define.XML and SDRG
• Generate CDISC(SDTM) compliance report using Pinnacle 21 Enterprise(Open CDISC) report for submission deliverables
• Worked on Up-versioning projects from legacy or SDTM (v 3.1.1) to SDTM(v 3.1.3) and SDTM(3.2)
• Proactively identify issues and contribute to solutions.

Confidential

Associate Manager

Responsibilities:

• Served as Associate manger on the corporate team.
• Project management, People Management, Resource management, Recruitment, Training and development.
• Participating with the client discussions to improve the process and suggesting the best ways of doing different activities and sharing the same with our internal team as needed.
• Provide technical expertise in conjunction with internal and external clients.
• Playing an advisory role and Interacting with vendors.
• Plan and coordinate database design, CDISC(SDTM) conversion, Define.XML, SDRG, eCRF annotation, SDTM compliance report and user support of clinical systems
• As Study Designer Ops Lead for all Rave Build activities which includes DB Design, EDC Programming and the change control activities.
• As a Production Migration Team Lead, managing a team of 8 people to co-ordinate all the migrations and plan the timelines to support clients.
• Mentoring different study build, programming and Rave Batch Upload Interface activities, Oracle Clinical data loads and the final Locks activities as per the client process.
• Program, test, and document databases in accordance with programming standards CDISC(SDTM) and validation procedures.
• Program database manipulation and transfers of data for internal and external clients.
• Mentor other team members and Lead Programmers in training and developing technical and/or database expertise.
• Independently bring project solutions to the CDP teams and the Clinical Data Programming department.
• Meet objectives as assigned, and interact with the project team to organize timelines, responsibilities and deliverables.
• Assisting IT department in developing and implementing new technologies.
• Assisting in developing, revising, and maintaining core operating procedures and working instructions.
• Meet objectives as assigned, and interact with the project team to organize timelines, responsibilities and deliverables.
• Develop and maintain good communications and working relationships with teams and external clients.
• CDM protocol design and clinical data management principles.

Confidential

Lead Programmer

Responsibilities:

• Plan and coordinate database design, CDISC(SDTM) conversion, Define.XML, SDRG, eCRF annotation, SDTM compliance report and user support of clinical systems
• Provide technical expertise in conjunction with internal and external clients.
• Program, test, and document databases in accordance with programming standards CDISC(SDTM) and validation procedures
• Playing an advisory role and Interacting with vendors.
• Program database manipulation and transfers of data for internal and external clients.
• Assisting in developing, revising, and maintaining core operating procedures and working instructions.
• Meet objectives as assigned, and interact with the project team to organize timelines, responsibilities and deliverables.
• Develop and maintain good communications and working relationships with teams and external clients.
• Interacting with corporate team and CDM team members to negotiate timelines, responsibilities, and deliverables.
• Served as Lead Programmer on the corporate team