Functional lead for the MDR module with a team size of 25 members Responsible for leading regular workshops & presentations with client stakeholders for system demonstrations and process clarifications Responsible for creating project plan with the Programme leadWork closely on functional design with technical architects and other SMEs (Subject Matter Experts)Generating detailed business and system requirements supported by use cases, wireframes, and workflowsDeliver MDR training to business consisted of more than 100 usersResponsible for tracking issues/risks/action items and supporting client team to execute UATResponsible for data migration from getting the right data from client to migrate it in the system using MDR admin toolLeading business process workstream to define the governance process for MDR and its interaction with GSK other systems

Working as a Business Analyst for a Pharmaceutical company to build Industry driven end to end Clinical solution - "Accenture Life Sciences Cloud". - Responsible for gathering, analyzing and documenting solution requirements using business process models, use cases and providing both functional and technical expertise. - Establish and maintain traceability matrix to verify requirements coverage and completeness. - Work with client stakeholders to ensure that captured requirements are measurable, testable and have an associated business benefit.

Perform requirement elicitation, business and technical analysis, use case modelling, maintain traceability matrix,feasibility studies, system design and quality support for all phases of SDLC. Perform needs assessment analysis and function as liaison between clients and technical team at offshore.Currently working for an end to end solution of a cloud based R&D Clinical Aggregated Environment – comprising of Oracle LSH and other applications

Study Design Consultant works closely with the client to guide them in study design and edit check development to deliver a high quality EDC system.• Review and provide input to proposals created by business development.• Provide input to the study management plan throughout the life cycle of the study• Provide training on technical aspects of EDC utilization and support the client's user community in the proper use of this technology• Work closely with the client to create the study design specification, custom database export specifications, and edit check specifications• Review database structure for consistency with project requirements, EDC specifications, and sponsor database standards• Review eCRF designs for logic, ease of use, conformance with protocol requirements, and consistency with sponsor standards• Responsible for designing and developing eCRF screens

•Design and development of eCRFs using MS Visio designer.•Design and development of edit checks and derivations using VB Script•Work with Study Services Specialist to design the best possible eCRF design for the trial•Contribution toward the development and maintenance of Work Instructions•Using SQL Server for Reporting and get the data from tables according to Customer requirement •Involved in various stages of Clinical trials using DataLabs.

•Estimation: Initially for each activity estimation is done as to how many person days that activity will take for completion and then accordingly person days are allocated for each day and members are assigned to do that activity.•Form Tech Review: It is initial stage of a trial development. It involves analysis of all the forms as to see all the forms are proper and trial can be hosted without errors.•Edit Check Tech Review: This activity involves detailed analysis of all the edit checks prior to trial development. It checks that logic provided for all the checks can be coded properly.•Trial Development: It involves development of the trial according to the estimation done. Team of 3-4 persons is assigned to complete the trial. One person leads the trial till the end and has the responsibility of completing the trial within the time allotted. •Trial Data Extraction (TDE): This activity involves extracting the data of patients from the Inform database for various data manipulations and analysis.•User Acceptance Testing (UAT) Issues: These are some changes and enhancement in the trial which the client asks us to do after the trial goes for testing in client’s environment. According to estimation a group of team does these issues according to strict timelines. •Change Order (CO): These are the changes and enhancements we have to do in the trial after the trial goes in the LIVE environment for capturing patient’s data. A team is assigned to complete the activity according to the person days assigned.