•	Provide innovative solutions, developing and delivering quality data conversion process as well as ensure operational delivery for oncology portfolio and eexpert knowledge in defensive programming techniques.
•	Responsible for the development, validation and review of study & standard programs/macros (Including SAS, PL/SQL.SPOTFIRE, R-Programming, Python) that support standard and study-level conversion of clinical trial data. 
•	Responsible for review development and validation of CDASH and SDTM Mapping to support management of data standards and studies, also review, development of aCRF, SDRG, Pinnacle 21 annotation and definexml for various standard or specific studies. 
•	Lead the Requirement gathering, development of specifications, Validation plans and performing end to end validation of Standard/Study macros. 
•	For complex programs & tools, oversee & coordinate a group of Programming Leads   
•	Support the programmers in trouble shooting and debugging of complex standard and study programs/macros. 
•	Act as a technical owner and/or reviewer/ultimate approver for tools and programs developed in SDTM Programming group. 
•	Establish and maintain effective working relationships with partners and stakeholders. 
•	Act as a coach & mentor for members of the team. 
•	Extensive knowledge of drug development process and working knowledge of GCP.
•	Knowledge on regulatory submissions (JPMA/PMDA) and hands-on knowledge on programming data conversions.
•	Has good communication skills and ability to effectively inform stakeholders of progress and challenges with deliverables.
•	 Able to conduct technical interview part of an interview panel.
•	Experience performing data conversion on large phase 3 oncology studies.
•	Experience converting structured and unstructured data from various sources including RAVE/InForm/Veeva as per GSK standards.
•	Experience with CRF automation process for SDTM annotations

Manager - Data Conversion and Standards

Covance

Associate Manager, Statistical Programming

Centre for Global Health Research, St.John's Research Institute

Key Professional Skills: 
Information Technology and Public Health Research Integration:
• Contribute to the conceptualization and design of IT applications for public health research 
• Complete understanding of the different process in hospitals and to correlate the same with the  Healthcare product
• Identifying IT application requirements for development
• Translation of application requirements from research team to the IT team for efficient application development
• Data Dictionary Development and end-to-end testing of healthcare IT applications
• Monitor progress of application development and brainstorm with inputs at each stage of product life-cycle
• Application deployment and field training to the clients/end-users
• Improving the performance of IT application through real-time analyses of collected data by extracting information from databases for e.g., MySQL, OLAP
• Training to the other staffs on the application testing and implementation
• Basic knowledge on EHR, EMR and US Healthcare system 
• SWOT and Gap analysis 

Product development/Project management:
• Manage project team within an Agile/Scrum environment
• Involve in test scenarios, product reviews and provide direction to delivery teams on scope, management & priorities
• Health Information System Management & Project Management
• Problem Analysis & Situation Analysis

Clinical, Public Health and Epidemiological Research:
• Supervise and monitor the field activities of public health research projects 
• Contribute to epidemiological study design, research methodology and development of Research/Project proposals
• Development of Clinical Trial and Public Health Research Protocols, SOPs and report writing as per the regulatory requirements
• Clinical Data Analysis with SPSS, R 
• Training module development and training on IT application use to field surveyors

Project Manager/Business Analyst

•  Independently manage the Barshi Health Study – communication and coordination of technical and field teams; training of field surveyors; management of logistics
•  Provide assistance in projects on Gaps Contributing to the Deaths (GCD) and the Point of Diagnosis of the Dead (PODD)
•  Assist software development team with technical support and inputs for software solutions for multiple field studies including ISHA, Man versus Machine (MvM), and others by creating/maintaining data dictionaries, testing applications, and maintaining documentation of processes.
•  Assist with the creation, organization, editing, upkeep of  MDS Operations manual and documentation
•  Programme implementation : pilot testing, project implementation, monitoring and evaluation, interim analysis, gap analysis, SWOT analysis

Senior Research Fellow

Public Health Field Study Implementation
•  Manage all implementation aspects of field projects throughout India
•  Liaise with senior physicians managing public health projects
•  Liaise and coordinate with technology management team
•  Assist with troubleshooting of field data collection software applications as needed
•  Synthesize and analyse public health data
•  Provide support to physicians using the coding platform for the Million Death Study
•  Implementation of Department of Biotechnology and International Science and technology partnership (Canada)-funded project (ISTP – DBT project: Cost-effectiveness of multiplex assay to assess HIV and syphilis infection in resource-limited settings) at St. John’s Medical College Hospital: 
         o Questionnaire development, Informed Consent Form development, Ethical clearances from institutional IERB. 
         o Data collection software development and testing 
         o Data collection quality check and monitoring  
         o  Data processing and analysis

Field Supervisor

Esteemed Clinical Research and Public Health executive, boasting a rich track record in steering clinical operations, shaping research policy, and orchestrating complex projects. Adept in orchestrating extensive surveys for data acquisition and harnessing advanced statistical methodologies to craft comprehensive reports, a true champion of health data analysis. Renowned for untangling intricate health information and distilling it into actionable insights, thus playing a pivotal role in informed healthcare decision-making. Recognized leadership attributes include visionary strategic planning, team empowerment, and stakeholder collaboration, resulting in impactful contributions to the field and organizational growth.

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