Kevindra Bhajbhuje
Wakad
Summary
Dynamic Principal Consultant with expertise in clinical trial management and data analytics at Xebia IT Architects. Proven track record in driving digital transformation and delivering actionable insights through effective product roadmaps. Skilled in SQL and project management, fostering collaboration and innovation across cross-functional teams to enhance operational efficiency. Sound knowledge and understanding of clinical trial management, drug pharmacology, patient journey, data analysis, data validation, development of domain specific KPI and visualization platforms, custom reports, agile methodologies.
Overview
14
14
years of professional experience
Work History
Principal Consultant/Domain Lead
Xebia IT Architects India Pvt Ltd
Pune
11.2023 - Current
- Defined product roadmaps and solution strategies aligned with R&D and clinical trial priorities to drive enterprise-wide data modernization.
- Requirement gathering and translating it into technical requirements and business solutions for unmet needs.
- Led high-impact analytics and data integration initiatives by assessing business value, system dependencies, and risk mitigation across cross-functional clinical domains.
- Spearheaded proof-of-concept (POC) pilots to demonstrate ROI and feasibility before scaling solutions.
- Delivered unified data platforms and clinical trial management systems, ensuring traceability between business objectives and technical implementation.
- Coordinated with IT, Digital, and Data Governance groups to manage integrations, system migrations, and the sunsetting of legacy tools.
- Directed a team of business analysts and domain experts, establishing development goals, monitoring velocity, and promoting continuous learning.
- Mentored analysts and developers on clinical domain standards, SDLC, and data tools, fostering collaborative knowledge-sharing environments.
- Acted as the central orchestrator between business, technical, and data teams to ensure the timely delivery of clinical trial digital assets and data products.
- Managed change impact analyses, milestone tracking, and issue resolution for platform deployments and enhancement cycles.
Lead Consultant - Life Science and Healthcare Data analytics
SAAMA Technologies
Pune
11.2018 - 11.2023
- Design, development, quality analysis of the developed clinical applications, business intelligence reports/dashboards for Life science and healthcare organization.
- Creation of product road map and releases with new actionable insights visualization, KPIs, risk indicator by defining the scope, enhancement and issue resolution.
- Develop product strategies, customizations, and product release timelines.
- Lead weekly project status meetings and be Primary offshore liaison to client for project execution.
- Demonstrated problem solving skill by understanding functional requirements, business needs and prepare business requirement documents (BRD), source to target mapping specifications.
- Performing gap analysis, data review and support to external/internal stakeholders on various medium to high complexity projects.
- Provide education and training to non-technical and new joiners on functional area and applications.
- Experience of Agile methodology, JIRA platform and end to end SDLC model and methodologies.
- Exposure to ETL technologies and Reporting tools like Tableau, Spotfire.
- Project 01: Clinical Trial Optimizer: Integration of Multiple Clinical Trial Data Sources (CTMS, EDC. Almac, IVRS etc.) in data model and Dashboard Visualization/Custom reports for Clinical trial operational and data matrices.
- Project 02: Clinical Trial Supply Chain: Review of structured and unstructured data from Clinical trial Supply Chain sources and created a dashboard to show high visibility of drug supply, inventory management, expiry, wastage, patient discontinuation and remove manual work.
- Project 03: Business Data Insights: Deep dive in data using SQL queries to the data source to identify any trend/outliers, observations that can have any impact on business/activities and validation and formulating insights using domain expertise, knowledge, comparing with industry benchmarks.
- Project 04: Clinical Monitoring- Patient level data surveillance: Automated process for reviewing patient clinical data to manage safety issues by the clinical team.
Centralized Monitoring Lead (Risk Based Monitoring & Clinical operations)
Quintiles (now IQVIA)
08.2015 - 11.2018
- Independently managing assigned clinical studies by coordinating in development and submission of key study documents, operations plans and study-specific tools.
- Coordination with third-party vendors for the data and project-specific requirements ensuring proper communication, reporting and tracking.
- Liaise with other internal departments and functions by providing clinical expertise and support.
- Early risk detection by review of data, non-compliance cases, potential issues and escalation to CPM.
- High-level data analysis and data trending using analytics tools and platforms and mitigation of the quality issue.
- Lead team for performing activities as per the protocol and SOPs by providing training, guidance and knowledge sharing.
- Resource forecasting and management throughout study period for various roles.
- CTMS champion, Trainer and mentor within department.
- Subject Matter expert eTMF, Data visualization platform and Excel.
- Part of many departmental initiatives like project QC, guidance document preparation and training material preparation.
Assistant Manager (Clinical Operations & Regulatory Affairs)
Regenerative Medical Services Pvt. Ltd.
04.2014 - 07.2015
- Coordination, negotiation and agreements with third-party for trial-related activities such as translation, data management, medical writing, and statistic.
- Co-ordinating with Sponsor, Investigator, IEC committee member and other site personnel.
- Complete and co-ordinate ethics committee submission in partnership with selected sites.
- Regulatory dossier preparation & submission to regulatory authorities such as DCGI, ICMR.
- Presentation before CBBTDEC and Subject Expert Committees of DCGI for clinical trial approval.
- Review of regulatory documents for accuracy, consistency, completeness and adherence to regulatory requirements.
- Co-ordination and SOP preparation for Institutional Committee for Stem Cell Research and Therapy (IC-SCRT) in Regenerative Medical Services Pvt ltd.
Clinical Research Associate (CRA)
Regenerative Medical Services Pvt. Ltd.
09.2012 - 03.2014
- Performing feasibility studies, site initiation visit, monitoring visits.
- Safety Monitoring and source data verification at sites.
- Trial related training to Investigator, sub-investigator and site personnel.
- Query generation and DCF resolution.
- Site closeout and archive documentation at the end of trials.
Clinical Research Associate (CRA)
Target Institute of Medical Education & Research
04.2011 - 09.2012
- Company Overview: (Clinical research organization)
- Set up and maintenance of study specific trial master files (TMF’s).
- Preparation and submission of site visit reports, minutes of meetings, note to files etc.
- Letters, notifications and follow ups for communication with personnel’s, authorities.
- (Clinical research organization)
Education
Certificate in Project management -
Manipal Global Education
01.2015
M.Sc. - Clinical Research
ICRI Mumbai-PRIST University
India01.2011
B.sc - Life science
N. H. College Bhramhpuri
Nagpur, India01.2008
Certificate in Nanotechnology - Nano Medicine
NSTC
Noida01.2007
Skills
- Clinical trial management
- Requirement gathering
- Business analytics
- Product roadmap
- Project management
- Agile methodology
- Data visualization
- Data analytics
- Digital transformation
- Forecasting and reporting
- Database-HIVE, Imphala,RDBMS, ORACLE
- SQL, Tableau visualization tool
- AWS, Redshift, Cyberduck
- Agile Tools: JIRA, AZURE
Therapeutics Area
- Stem cell therapies
- Cell therapy for Cartilage & Bone regeneration
- Dermatology
- Osteoarthritis
- Diabetes
- CVD
- Infectious diseases
- Crohn’s diseases
- Umbilical cord blood transplantation
- Herbal products for anxiety, diabetes and pain management
Awards And Appreciations
- Quarterly Star Performer, For stepping up and performing work outside of responsibilities.
- Shout Out, For proactive approach and helping others team members.
- Bravo, For technical support and timely project deliverables.
- Applause, For outstanding contributions.
Appreciations
- Sneha Utterwar, 11/01/19, Kevindra has been a great value add to the team with his in-depth domain knowledge. He is playing a vital role in one of the important projects to ensure that the development team understands the requirements and translate them.
- Amrapali Nikam, 2017-2018, Appreciate his expertise and mentorship that he provided to the team to get the desired result for the project delivery and has influenced the internal and external stakeholders to derive a positive business outcome.
- Tarannum Kashmiri, 2016-2017, Kevindra was one of the stars of my team. He has showcased expertise in almost all areas of his work. He is an asset to the project and continues to impress everyone with this sound technical acumen.
Languages
- English
- Marathi
- Hindi
Profile Snapshot
A clinical research and patient data analytics professional with experience at CRO, sponsor and IT organization. Sound knowledge and understanding of clinical trial management, drug pharmacology, patient journey, data analysis, data validation, development of domain specific KPI and visualization platforms, custom reports, agile methodologies. Participating in innovations for clinical trials and life science product development. A strong communicator with the ability to interact effectively with stakeholders at all levels. Effective people management by leading, review, and approve the work of other business analysts/resources assigned to projects.
Language Proficiency
Marathi
First Language
English
Advanced (C1)
C1
Hindi
Proficient (C2)
C2
Timeline
Principal Consultant/Domain Lead
Xebia IT Architects India Pvt Ltd
11.2023 - Current
Lead Consultant - Life Science and Healthcare Data analytics
SAAMA Technologies
11.2018 - 11.2023
Centralized Monitoring Lead (Risk Based Monitoring & Clinical operations)
Quintiles (now IQVIA)
08.2015 - 11.2018
Assistant Manager (Clinical Operations & Regulatory Affairs)
Regenerative Medical Services Pvt. Ltd.
04.2014 - 07.2015
Clinical Research Associate (CRA)
Regenerative Medical Services Pvt. Ltd.
09.2012 - 03.2014
Clinical Research Associate (CRA)
Target Institute of Medical Education & Research
04.2011 - 09.2012
Certificate in Project management -
Manipal Global Education
M.Sc. - Clinical Research
ICRI Mumbai-PRIST University
B.sc - Life science
N. H. College Bhramhpuri
Certificate in Nanotechnology - Nano Medicine
NSTC
Similar Profiles
Rambir SinghRambir Singh
Assistant Manager Finance & Accounts at Xebia IT Architects India Pvt LtdAssistant Manager Finance & Accounts at Xebia IT Architects India Pvt Ltd
Arun Deepika FrancisArun Deepika Francis
SENIOR CONSULTANT at XEBIA IT ARCHITECTS INDIA PVT LIMITEDSENIOR CONSULTANT at XEBIA IT ARCHITECTS INDIA PVT LIMITED
LOVE KUMARLOVE KUMAR
Lead Consultant at Xebia IT Architects India Pvt LtdLead Consultant at Xebia IT Architects India Pvt Ltd
Ankur SrivastavaAnkur Srivastava
General Manager – West Africa Region // 2W & 3W (Sales, Service Spares) at Bajaj Auto Ltd.General Manager – West Africa Region // 2W & 3W (Sales, Service Spares) at Bajaj Auto Ltd.
Sachin Vitthal BadeSachin Vitthal Bade
Senior Executive at Wipro Ltd.Senior Executive at Wipro Ltd.