Sudhansu Mishra
Associate Advisor - Clinical Data Strategist @Eli Lilly and Company
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WORK HISTORY
Associate Advisor - Clinical Data Strategist @Eli Lilly and Company
IN
Accountable for setting end to end clinical data strategy, driving cross functional alignment, and realizing improvements in drug development data solutions, technologies, data processes, data products and services.Responsible for consulting with and understanding end to end global clinical data sciences and clinical data management, including database structures, data collection methods, data flow management, data analytics and automations, data quality & integrity, data technology, data archiving, data standards, data integration, data mapping, normalization and data submission.Support efforts to recruit, develop, and retain a scientific, technical and operationally capable workforce skilled and knowledgeable in end-to- end global clinical data strategies, data base structures, data normalization, automation, analytics and data integration.Define and drive data strategies to accelerate data execution, delivery, integration, and submission.Articulate the value of data solutions in terms of reliability, time, cost, quality, and scalability.Integrates cross-functional and/or external information and applies technical knowledge to data-driven decision making.Interacts with regulators, business partners and outside stakeholders on business issues.Thinks with end to end in mind consistently managing risk to minimize impact on data delivery.Bring greater value to the portfolio by anticipating issues and identifying opportunities for which datasolutions can be applied regardless of source.Articulate the value of data solutions in terms of reliability, time, cost, quality, and scalability.Integrates cross-functional and/or external information and applies technical knowledge to data-driven decision making.Anticipate and resolve key technical, operational, or business problems that impact the Data andAnalytics organization.Develop and test new ideas and/or applies innovative solutions that create value to the portfolio.
EDUCATION
Biju Patnaik University of Technology, Rourkela
Master's degree, Pharmacy, Pharmaceutical Sciences, and Administration
SKILLS
ABOUT SUDHANSU MISHRA
With over a decade of experience in Clinical data management,I am extensively involved globally in trial set-up, conduct and closure phaseI am also fascinated about Automation and my inclination to Machine learning and RPA enabled me learning UIPATH, MS-POWER AUTOMATE by which I have created many BOTs that increase my day to day productivity and also it\'s exciting to learn new things as it poses challenges and new scope for research and learnings.I have completed 3 months SAS and CDISC Internship and completed project on SDTM, preparing, mapping and programming of AE,SV,TA,TE,DM,VS DOMAINS.Being a Project Manager (PM), I undertake the complete responsibility of a trial right from the Protocol outline, through study set up, conduct and close out. I also manage multiple CRO EDC vendors, Lab vendors throughout the course of the trial. As PM, I also provide my inputs to, Monitoring Plan, Protocol Deviation Plan, RFP, Lab specification, DMP, DVS, EDIT check specifications. I am responsible for preparing the data flow plan, Study set up timelines, Blinding plan,MOCK CRFs for the CRO EDC vendors.I have completed my Master’s in Pharmacy and additionally a Post Graduate Diploma in Clinical Research and Pharmacovigilance (PGDCRP). In my role as Manager, dealing with too many data necessitated me to learn EXCEL VBA programming and with this skill-set I have prepared tools/templates to manage clinical data. This has resulted in benefiting not only me, but also my team members to manage their projects well with productivity.I always strive for agility and simplicity cutting the complex aspects of the process in order to increase the productivity by optimal usage of the resources. I am the part of Process excellence group where I lead a project with the objective of utilising Artificial intelligence/Machine learning/Natural processing language in Clinical research and Data management.Methodological, self-disciplined and with an impeccable work ethics enables me in proactively managing important time-sensitive trials/projects, balancing stakeholder expectations with those of the trials/projects and working collaboratively with study group members to establish an efficient and effective delivery of data for successful database lock.Personally, I am a fun loving individual, a foodie and love to cook and you can find me in the kitchen during my free time.
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