Associate Director of Process Excellence
DR Reddy's Lab
Total years of experience :16 years, 4 Months
Analysis of department and corporate goals, development of performance indicators and Metrics with the goal of removing waste and improving efficiency.
Lead Implementation of ArisGlobal Inquirer for Triaging and Responding to inquiries that solve complex problems that can have broad impact on the business with SDLC methodology.
Team leader for Development of innovative services, processes to address current and future problems in Signal Detection Systems program.
Vendor Management and application selection: Worked with Regulatory department in management of Regulatory Information Management Systems (RIMS) selection to manage regulatory submission plans and submitting the output to Regulatory agencies.
Worked with Oracle Empirica, SAS JMP, Drug logic, ArisGlobal, SpotFire, and Pharmacovigilance Manager from Extedo, TAKE Solutions, UBC Clarity and ENNOV for Signal detection application.
Lead programs with significant risk and complexity to achieve milestones and objectives in the Global Lean Laboratory initiatives
Worked with cross-functional teams in India to explore Corporate Central Sourcing for Labs, Vendors and other service providers.
Team Leading in the investigation and implementation of Clinical Data Warehouse for acquisition, storage and analysis of all businesses data acquired during mergers and acquisitions.
Developed communication strategy and plans to raise awareness and influence behaviors across the organizations Lean six Sigma program.
Worked with IT team to analyze SAP HANA process for manufacturing data acquisition and improvements.
IT team lead in implementation of Learning Management System (LMS).
Worked with Finance team to manage project budget.
Proactively work with Clinical R&D Trial investigators team to establishes IT project feasibility by examining project alignment
with organization strategies and plans; completing cost-benefit and information, technology, and systems integration analyses.
IT team lead for implementation of a patient education and clinical trial portal that will track disease stages with and without
treatment regimen through effective communication with both technical and non-technical teams. Developed Management
policies, Governance and Process/Metrics selection procedures.
Worked with a team of investigators to develop an analysis and predictive tool for selecting suitable sites and investigators for
Clinical Trials. Utilized analytic tools Qlikview and Tibco Spotfire to extract data from Impact CTMS system for data analysis,
Metrics development, visualization and simulation for effective decision making.
Developed the Project SharePoint sites to enhance collaboration between internal and external stakeholders to ensure efficient
communication during implementation of solutions.
Worked with Clinical Protocol development team to investigate applications and processes for the efficient management of
protocol. Investigated Protocol management applications from NIH and other vendors.
Analyzed protocol development process by doing a VSM, developed new efficient processes with Design For Six Sigma (DFSS) and Metrics to track business goal
achievement.
Company representative on CRO systems initiatives that will impact the clinical trial industry. Communicated and managed
relationship with Covance, Quintiles and PPD.
Team Lead in the development of Metrics in IMPACT CTMS and Oracle Argus implementation with SDLC methodology.
Trained R&D team on Lean Six Sigma principles and led process mapping sessions with VSM, determination of process value
for business, removal of muda (waste) to make process efficient, effective and reduce operational cost
Prepared IT project status reports by collecting, analyzing and summarizing information and trends.
Maintained project data base by developing information requirements; designing an information system to perform project
requirement analysis.
Collaborated with IT to develop and manages project schedule, budget and implementation plans that led to improved process
and reduced cost by $1 Million.
Change management champion - ensuring all technical changes are properly scheduled and completely reviewed by the business
and technology leads and approved for implementation.
Developed project plans and documentation for the Implementation of Oracle Argus, ARISg and ARISg Register.
Developed Process Metrics and optimization procedures for Laboratory and Clinical systems implementation.
Worked with the program director to defined scope and objective. Defined industry standard methodologies in the area of
infrastructure, software deployment, desktop engineering and integration of different projects
Planned, monitored and controlled multiple projects across the program with a focus on milestones/deadlines, deliverables,
budgets, resources and managed relationship key stakeholder that led to a reduced project cost.
Developed business plans and collaborated with cross functional teams to identify operational issues and develop innovative
solutions with the use of Lean Six Sigma and other process improvement methods.
Analyzed business processes and provided thought leadership to address issues relating to efficiency and effectiveness to
improve productivity.
Led efforts to develop change management plans to ensure program to success.
Gathering, translating, managing requirements and business rules for Systems analysis and Design.
Development of Statement of Work (SOW), contracts and bid documents.
Responsible for the strategy, execution and delivery of R&D Clinical system projects through adherence to all IT project standards, defining and managing the project through the SDLC and Agile methodologies.
Ensured 21CRF Part 11 compliance for all project related in implementing Oracle Clinical, TMS, Argus, EDC, ARISg and
ARISg Register within budget, scope, time with the assurance of project quality. Global Validation plans achieved 2 Million
cost reduction. Expert in the use of Lean, Six Sigma and SDLC methodologies to ensure effective systems implementation.
Worked with Oracle personnel to implement Electronic Data Capture (EDC) systems (Oracle Inform).
Led a technical team to develop edit checks, custom reports, data extracts, User Acceptance Testing (UAT), system release and
system user training documents.
Led teams to develop Validation Master Plan and manage the validation of OC/TMS, Argus and ARISg.
Developed fixed and operational budget for systems implementation efforts. In-depth knowledge of CDISC data format for regulatory submissions.
Gathered, translated and managed complex requirements, business rules for Systems analysis and Design.
Managed $120 million Clinical and Regulatory systems program.
Managed Project Managers, DBA’s, Validation and Testing teams for project success.
Trained R&D personnel (Clinicians, Programmers, Data Manager, and Clinical Research Associates) in Lean Six Sigma
methodology, Process Mapping, 5S, development of Metrics, Key Performance indicators (KPI’s) and using them to track
business goals.
Identified requirements, related risks, constraints and issues, communication and adjusted work plan for the implementation of
Oracle Thesaurus Management Systems (TMS).
Managed the implementation of TMS with SDLC methodology and successfully loaded and tested medical dictionaries
COSTART, MEDDRA, ICDA9 and WHODRUG for effective coding.
Utilized SQL*PLUS to extract data and reports from Clinical database.
Trained Clinical R&D users in new system functionalities.
Worked closely with company R&D leaders to define project objectives, budget, and schedules and oversee quality control
throughout the implementation and delivery of Clinical and Regulatory systems OC/TMS, SAS and ARISg.
Administered user privileges to ensure 21CRF Part 11 compliance.
Developed Standard Operating Procedures (SOP).
Tracked progress and reviewed project tasks to make certain deadlines and budgets are met.
Proactively communicated project status, issues and risks to management and maintain time-lines and target dates for
implementation of Oracle Clinical 3.1. to R&D directors.
Developed SAS Listing for Clinical Investigators.
Measured and monitored progress at clearly defined points in the process to ensure that projects are delivered on time, within
budget, and that it meets or exceeds expectations.
Team member in the implementation of Enterprise Laboratory Information Management Software (LIMS) and Electronic Lab
Notebook (ELN).
Developed extraction process for active ingredients in the Lab, Pilot Plant and Manufacturing