Irfan Kutubuddin Attar Email & Phone Number

Chennai, Tamil Nadu, India

Working as a Business Analyst or Functional SME to help Life Science organisations develop high end software products. This in turn helps in accelerating clinical research work thereby bringing critical drugs faster to the market and saving patient lives.

Mumbai Metropolitan Region

Project: Cognizant Clinical Data Platform, Patient & Operational Repository, Analytics (Clinical Data Insights - CDI)Team size: Approx. 20Client implementations: Implementations: 3 (US & EU based Fortune 500 Biotech & Pharma companies)As a Product BA, collaborated with a mixed software development team (Hybrid-Agile mode)> Like: Product Owner, PM, Architect | UX/UI/Core App | Data Exchange | ETL | Database | Analytics | Helpdesk, Infra, DevOps, AWS, in designing and testing new product features till its Production implementation in client environments. > Worked with client POCs to capture end user requirements to design prototypes / wireframes of new features or enhance or customize existing product functionality.> Based on end-to-end clinical data flow and module enhancements/new features, created detailed Product documents like: Change Request(CR), Use Cases, Functional Requirement Specification (FRS/BRD), RTM, User Manuals, Product Release Notes and more. > Delivered approx. 4 CRs per year to enhance CDI platform and offered newer features. Also worked closely with Cognizant LS Compliance/Delivery Excellence/Regulatory & Security teams to perform LS Risk Assessment of new features as per guidelines: GxP, 21 CFR, Annex 11 etc. > Attended 1 platform assessment exercise by an external vendor along with Cognizant LS Compliance/Delivery Excellence teams. Assisted teams from initial product demo till risk closure phase.> Guided Dev, QA & Performance testing teams to prepare test scenarios, test data and manage defects.> Analyzed emerging market trends to document use case backlog and collaborated with Product Owner to prioritize them in upcoming Sprints. Also provided support to lateral POCs during RFPs to showcase CDI.> Acted as POC to deliver product demos to internal/external stakeholders, clients and vendor companies and as a team, implemented CDI platform for 3 Pharma/Biotech clients.

Mumbai Metropolitan Region

Role : CDR Lead – Clinical Data Repository(CDR)Client : US Fortune 500 Biotech & Drug Manufacturing CompanyDomain : Life Sciences | Team Size : 5•Managed a small team of 5 to plan, assess metadata variables of Oracle Clinical studies and CRO/External source variables to map/load study data into JANUS-like CDR database in CDISC SDTM format across different trial phases and various therapeutic areas for legacy/locked and on-going studies> Attended onsite visit (US) for system KT and SDTM mapping process training> Administered project SLAs, metrics reporting, people management, project vision and strategy > Guided team members in mapping complex SDTM maps and supervise ETL jobs during Inbound-Outbound data load stages> Liaised with client CDR POCs to ensure end to end data loading is successfully achieved per study/schema> Provided ideas to innovate SDTM mappings/loading procedures, suggested long term business improvements•In parallel, managed two member Life Science Contracts and Events Management team for a Biotech client supporting US Sunshine Act data aggregation and reporting.•Also in parallel, supported PM in handling a large CDM engagement for Biotech firm covering end-to-end CDM activities.• Supported company initiatives of Data Standardization system design which would help in analytics and reporting, ISS, ISE, business decisions, historical drug performance review etc. [Tools linked to CDSIC SDTM Data Standardization system were : RAVE EDC, Legacy IT systems, Vendor Apps, Master Data Management DBs and more]Tools used: Client-owned SDTM mapping tool, SQL Developer, Specifications via Excel, Word

Mumbai Metropolitan Region

Role: Functional Consultant/SMEClient: UK/US Fortune 500 Pharma company> Worked as SME to collect requirements, process enhancements and UAT test features released for client implementation as part of Cognizant automation and system integration initiatives using 'Setup Smart' (Edit check automation) platform.> Worked with Development team to create customized Study Reports (Rave Custom Reports) as per client requirements.> Worked with Application Development (.Net and BO Reports Developers), QA and Infra teams to implementation 'Setup Smart' and newly designed Rave Custom Reports in Production environment> Worked with PM to assess benefit analysis post the production release and document the same> Conducted trainings & feedback sessions for Business teams(Clinical Data Managers) and Support teams as part of process transfer, new application maintenance & change request proceduresTools used: Rave EDC 5.6.x Classic, Rave Reports(Business Objects), Cognizant 'Setup Smart'.

Greater Bengaluru Area

Role: Lead Protocol Analyst (Technical)Team size: 8Client: US Fortune 500 Pharma companyUnderstand the Inform EDC eCRF from SDTM Annotations point of view and design: SDTM Specifications Spreadsheet and Define, for Programming team, per SOPs and SDTM Implementation Guide.Good understanding of Standard eCRFs, Protocol Specific and External LABS.> Attended onsite visit (US) for system KT and SDTM mapping process training> Liaison between the SQL programming team and Onshore Client teams for a smooth onshore–offshore operation. > Coordinate effectively with internal teams: SDTM Mapping Programming, QC, Data Entry, Deployment, till the Study reaches DBL (Database lock).> Coordinated with Global Clinical Study teams to meet the Study timelines/milestones like: SDTM Package deployment to UAT (includes Inform SDTM UAT and CDR Data Flow UAT), SDTM in Production. Database Lock/File Freeze.> Participated in Process Improvement meetings to assess Table Trans codes and Inform EDC Architect. > Provided SDTM mapping solutions for continuous improvement and performance tuning.> Applied complex changing needs of the Trial in SDTM Spec and Define, in case of a Post Production Change.> Used SQL Developer extensively to query UAT environment for UAT analysis based on SDD Extract done by the Onshore Clinical Statistician Team to avoid repeat UAT errors.> Identified bugs/findings in Standard SDTM Spec, Define and Standard Annotated eCRF. Submitted the findings to Client for review and proposed solutions to Standards and Codes.> Identify quality issues during the study through regular review of the data, data flow information and quality> Responsible for giving training to the new trainees and checking the quality of records.Tools used: SQL data extraction/SQL Developer, InFrom EDC, SQL scripts, Metadata analysis via Excel, SDTM Mapping tool 'TableTrans'.

Greater Bengaluru Area

Role: eCRF Developer/QATeam size: 10> Performed Software QC Testing (manual) on eCRFs built on – Medidata Rave 5.6.x and InForm 6.x EDC Platforms.> Successfully QC tested Simple and Complex Edit Checks (Data Validations) with 1.5% error escape rate.> Created test plans, decided testing strategies, written test cases for - Unit level and functional testing.> Effective defect tracking and reporting to improve communications and reduce delay.> Also QC tested Clinical Reports built in Crystal Reports. This was a manual testing method by understanding the Clinical Reports Specifications document. Was part of pilot project in testing of Clinical Reports and SAS Outputs.> Also worked as an eCRF Developer/Programmer on RAVE 5.6 Platform. Built Standard and complex (Protocol Specific) eCRFs as per Study Requirements and SOPs.> Worked with the supervisor during Client Audits on QC Documentation and Work Order Management using BMC Remedy Tool.> Communicated software testing defects to QC Management & Development teams for correction/escalation and participated in Client Meetings to address research options.> Worked with the eCRF and Database Design Development/Configuration teams to understand complex logic in the eCRFs, and provide QC feedback for process improvements.Tools used: Rave EDC 5.6.x Classic, InForm 6.x EDC, Microsoft Excel/Word for Specifications

Mumbai Metropolitan Region

Role: Tech Support - Broadband L1 teamClient: SBC Yahoo DSL> Worked on troubleshooting & resolving DSL Telephone line Broadband Internet related issues.> Ensured that Service Level Parameters set by the client are met with; Customer Satisfaction (CS), First Contact Resolution (FCR). Maintained an average CS & FCR Quality of more than 87%.> Avoided Repeat customer contacts for 89% of initial interactions.> Ensured that every client interaction has a detailed Issue Documentation, in the PeopleSoft Customer Database.> Attended onshore Client meetings for new product testing and support.> Mentored the team on process updates and new testing technologies and trained the new joiners for KT sessions.> Provided a presentation on Line Testing Tools, on how we can integrate them into one screen for faster customer service, and improve team performance. This idea was selected and implemented by the leadership team.Tools used: Unix-based network testing tool and troubleshooting app. Ticket management (Documentum)

Role: Tech Support - Remote AdminClient: US Computer Systems company (Gateway Inc.)> Worked in troubleshooting & resolving various software and hardware issues, related to Desktops and Laptops machines, using CF1 Remote Administration Tool.> Credible for meeting overall Service Level Parameters like Customer Satisfaction, First Contact Resolution, and Avoiding Repeat contacts. Technical Support Quality Requirements were always between 85% to 90%.> Ensured that every client interaction has a detailed Issue Documentation, in the Siebel CRM Database.> Kept abreast with emerging trends in Computer Systems Industry and participate in process updates and KT sessions conducted by the Client> Created Standard Customer Script for Chat Tool; this was approved by the client to include as ‘Automated Messages’ in the Chat Tool for Technical Support interactions.Tools used: Remote Admin tool (CF1 proprietary tool), Ticket management (Siebel)

Mumbai Metropolitan Region

Role: Faculty> Conducted Theory and Practical Sessions/Laboratory Experiments related to Electronics, Computer Hardware and System Maintenance.> Worked on administrative responsibilities assigned by Training Manager, like generating various training reports for course filing and documentation.> Created unique and memorable classroom experiences during the tenure.

Bachelor Of Engineering - Be, Electronics

Activities and Societies: Certifications / Trainings / Sessions:- >> Completed Google Cloud, Generative AI online trainings (Oct 2023) >>.

12Th Hsc (Higher Secondary School Certificate), Science

10Th, Ssc (Secondary School Certificate)