Nazifa Shakla Email & Phone Number

India

- Drive the execution of all product lifecycle processes for products, including product research, market research, competitive analysis, planning, positioning, roadmap development, requirements development, and product launch.- Translate product strategy into detailed requirements for prototype construction and final product development, testing, validation, and launch using Agile framework.- Analyze market data to develop sales strategies and define product objectives for effective marketing communications plans.- Develop product positioning and messaging that differentiates Saama product and its features across primary market segments.- Accelerate the SDTM regulatory Submission artefacts (Sponsor & non - Sponsor clinical studies) using pre-trained models (AI models trained on Industry Metadata & data)

India

-Managing 51 Clinical Application maintenance and enhancement Service Delivery IT support for raised Incidents, Change Requests and Service Requests within agreed SLA-Managing team for Interface development and migration support for Client prestigious Score program (a Clinical transformational roadmap to migrate applications on NextGen applications and environments)-Managing team for Impact assessment, testing and validation support for Argus E2BR3 upgrade from Argus E2BR2 and Inform 6.3 upgrade-Focus on Agile implementation in AMS – implemented Kanban Visual board in ServiceNow for Incidents, proposed ideas to generate Burndown Chart in TFS2012 for Capacity Planned in Clinical area for received Service Requests.-Formulating various reports including Weekly Status Report and Monthly Status Report for external and internal stakeholder periodic communications.

Noida Area, India

* Coordinate with business stakeholders and technical experts to identify solution for auto ingestion, linking and transforming various data sources (structured/ unstructured) using Cognitive Methods* Led the Innovation Council Team to showcase the generated ideas in niche area to customer by using the cutting-edge technologies like Python, R, NLP, Tableau, Shiny* Developed test scripts around generated RDF and Property Graph in Knowledge Graph database (Neo4j) and simulated in the form of a prototype* Actively participated in workshop and supported platform development work related to Common Information Metadata Model(CIMM), Semantic and Knowledge Repository for Universal Translator.* Maintained close coordination with general SME related activities for Life Science 1 North America

Noida

•Manage E2E project governance of two business critical projects right from project kick-off meetings to deployment in production in Clinical Data Standardization and Harmonization space to provide an enterprise-wide generic solution to comply with FDA regulatory mandate to submit data in CDISC-SDTM format.•Collaborate with the customer for strategic decision-making process to conceptualize and implement innovative enterprise-wide solution approach to build a global library for both Legacy and EDC study data conversion across the portfolio into SDTM3.2 through the button and click process that can be readily used for downstream processing (ADaM and TLF generation).•Spearhead a team for development and integration of generic mapping specifications, utilities, and programs for Clinical Endpoints across various Therapeutic Areas. Delivered over 200+ Endpoints global utilities and programs in the shortest possible timelines.•Primary Point of Contact for all the Project related queries, gap analysis, provide the solution and define strategies•Provide a functional solution, perform quality analysis and coordinate with a cross-functional team to resolve any issues/concerns rose during the data transformation process.•Coordinate development activities, evaluate and report performance of the project to involved stakeholders.•Ensure adherence to quality processes and participate in the audit, NC’s closure, resource hiring, training, mentoring, appraising, budgeting, forecasting and invoicing.•Conduct Fun at Work and several CSC activities to increase productivity.

Noida

Manage all frozen and live Clinical Data standardization and harmonization projectrequirement for Legacy, EDC, In-Licensed, Joint-Venture and Outsourced trials for all major Therapeutic Areas (Oncology, Respiratory, Cardiovascular, Infectious Disease, Endocrinology, Opthalmology).Build capability to continously improve the team ability to aggregate, transform and manage data in a rapid, affordable and agile manner. Support ongoing and future initiatives to enhance, roll-out, and expand capabilities of key technology solutions.Collaborate with business stakeholders to prepare responses for submitted data to regulatory agencies for key compounds.Review, analyze and evaluate business systems, tools and information needs for project scope.Build and maintain strong business partnerships to facilitate the continued evolution of technologysolutions and identify other processes/areas where these solutions may be beneficial.Take leadership and/or support other assigned projects or initiatives within the group Technology & Automation solutions team.Conduct business user requirement meeting, project status meeting with Global User Group, Business Sponsor and to discuss roadmap and change in project scope/plan.

India