Krishnendu Sengupta Email and Phone Number
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Krishnendu Sengupta personal email
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I am an experienced executive with 14+ years of experience in Pharmaceutical / Clinical R&D domain. I have in-depth knowledge in clinical data management using paper,EDC system and spotfire along with 10 years of centralized monitoring / risk based quality management(RBQM).I have worked in multiple therapeutic areas, predominantly in cardiovascular therapeutic area, across all the phases of the trial. I am well versed with the • Industry current trends• Strong medical knowledge associated with cardiovascular and diabetes.• Managing mega global trails (patient populating ranges from 8000 to 27000+)• Patient profile review from a medical prospectiveI also have a established track records of developing analytical model for data analysis, Natural language processing for serious adverse event investigation, predictive analytics etc.Key highlights:• Certified in “design thinking” and “application of machine learning in health care”.• In depth knowledge in creating data analytics / review visualizations.• Respectable knowledge in developing clinical research apps for virtual trials and proto-type for virtual identification of subject population (developed during a hackathon)• Experienced in managing multiple stake holders like medical directors, global project managers, CRAs, Bio-statistics, direct reportees, team members as a project lead etc.
Astrazeneca
View- Website:
- astrazeneca.com
- Employees:
- 59317
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Director - Centralized MonitoringAstrazeneca Sep 2023 - Present
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Associate Director, RbqmAstrazeneca Aug 2022 - Sep 2023
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Associate Director Medical Data Review (Risk Based Monitoring)Iqvia Aug 2021 - Aug 2022Bengaluru, Karnataka, India•Manage project milestones, functional department, recruitment, resourcing, utilization, productivity, internal and external customers •Manage a functional Department of staff, applicable regulations appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters. •Provide SME support and mentor staff •Provide technical advice and solutions with internal and external customers to solve problems and improve quality and efficiency.•Participate in defining strategies for new processes and technology at either regional or global level. Ensure that staff is trained and compliant with current operating procedures and work instructions and project scope of work•Attend customer meetings and lead discussions of project requirements and strategic planning•Manage relationship with customer at both the project team level and with functional peers•Provide operational input into proposals and scope of work. Participate in proposal defenses. Provide input to costing algorithms, particularly at the customer level -
Senior Manager Medical Data Review (Risk Based Monitoring)Iqvia May 2019 - Aug 2021Bangaon Area, India• With organization’s policies and applicable regulations appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters. • Maintain strong customer relationships • Managing head counts and customer billing / finance activities • Represent clinical data scientist at multi-disciplinary team meetings and external client meetings.• Drive multiple operational initiatives and business enhancement.• Manage staff in accordance• With guidance, track service performance and provide leadership to identify root causes of issues and implement remedial actions • Ensure data quality focus to audit readiness with Clinical Compliance and Systems Validation Compliance. • Conduct in-stream data trend analysis in support of data quality and integrity (includes protocol compliance and targeted review of patient data)• Ensure timely follow-up and resolution of compliance issues • Serve as Subject Matter Expert (SME) • Continuously look for opportunities to improve efficiency of tasks and quality of deliverables • Provide therapeutic area/indication training for the project clinical team.
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Manager Medical Data Review (Risk Based Monitoring)Iqvia Jul 2018 - Apr 2019India• With organization’s policies and applicable regulations appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters. • Maintain strong customer relationships • Represent clinical data scientist at multi-disciplinary team meetings and external meetings.• Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested. • Manage staff in accordance• With guidance, track service performance and provide leadership to identify root causes of issues and implement remedial actions • Ensure data quality focus to audit readiness with Clinical Compliance and Systems Validation Compliance. • Define data capture requirements in line with protocol and reporting needs. • Conduct in-stream data trend analysis in support of data quality and integrity (includes protocol compliance and targeted review of patient data)• Ensure timely follow-up and resolution of compliance issues • Serve as Subject Matter Expert (SME) • Continuously look for opportunities to improve efficiency of tasks and quality of deliverables • Provide therapeutic area/indication training for the project clinical team.
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Medical Data Review Manager (Risk Based Monitoring)Iqvia Apr 2017 - Jun 2018Bangalore• Serves as a medical data reviewer (MDR) and Identify any medical and complicated anomalies in patient reported data by performing Subject Level Data Review that require further investigation with the clinical site to determine overall accuracy.• Conducts in-stream data trend analysis in support of data quality and integrity (includes protocol compliance and targeted review of patient data).• Ensures data quality focus to audit readiness with Clinical Compliance and Systems Validation Compliance.• Serve to implement innovations.• Defines data capture requirements in line with protocol and reporting needs.• Provide project management service to the team and viewed as an expert in data management.• Drive the delivery of end-to-end study data quality and integrity.• Provide medical, clinical, and scientific advisory expertise.• Maintain strong customer relationships.• Serve as Subject Matter Expert (SME).• Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.
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Associate Medical Data Review Manager (Risk Based Monitoring)Iqvia Apr 2015 - Mar 2017Bengaluru Area, India• Serve as a Medical Data reviewer (MDR) and Identify any anomalies in patient reported data by performing Subject Level Data Review that require further investigation with the clinical site to determine overall accuracy.• Conduct in-stream data trend analysis in support of data quality and integrity (includes protocol compliance and targeted review of patient data)• Provide project management to the team and viewed as an expert in data management.• Drive the delivery of end-to-end study data quality and integrity.• Provide medical, clinical, and scientific advisory expertise.• Act as a clinical data scientist for performing data analytics by reviewing the visualizations, identify potential issues of concern and present at multi-disciplinary team meetings and external meetings.• Ensure data quality focus to audit readiness with Clinical Compliance and Systems Validation Compliance. • Define data capture requirements in line with protocol and reporting needs.• Maintain strong customer relationships. • With guidance, track service performance and provide leadership to identify root causes of issues and implement remedial actions.
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Assistant Medical Data Reviewer Manager (Risk Based Monitoring)Iqvia Apr 2014 - Mar 2015• Serve as a medical review point of contact for one or more protocols.• Identify patient anomalies to ensure medical congruency/plausibility of a subject data per protocol.• With minimal guidance, provide project management expertise working with clinical study teams, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise.• Maintain strong customer relationships.• Serve as Subject Matter Expert (SME).• Continuously look for opportunities to improve efficiency of tasks and quality of deliverables.• Provide therapeutic area/indication training for the project clinical team.• Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested
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Senior Medical Data Reviewer (Risk Based Monitoring)Iqvia Apr 2013 - Apr 2014• Serve as a medical review point of contact for one or more protocols.• Identify patient anomalies to ensure medical congruency/plausibility of a subject data per protocol.• With minimal guidance, provide project management expertise working with clinical study teams, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise.• Maintain strong customer relationships.
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Senior Clinical Data Coordinator (Risk Based Monitoring)Iqvia Apr 2012 - Mar 2013Bengaluru Area, India• Serve as a Data Operations Coordinator (DOC) for one or more protocols • Exhibits leadership role in area like UAT, DB testing or process on a large study with guidance.• Conduct data review including query management.• Lead database audit team.• Develop and maintain good communications and working relationships
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Clinical Data CoordinatorIqvia Apr 2011 - Apr 2012Responsibilities and Achievements• Serve as a Data Operations Coordinator (DOC) for one or more protocols • Exhibits leadership role in area like UAT, DB testing or process on a large study with guidance.• Conduct data review including query management.• Lead database audit team.• Develop and maintain good communications and working relationships
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Associate Clinical Data CoordinatorIqvia Aug 2009 - Apr 2011Responsibilities and Achievements• Serve as a Data Operations Coordinator (DOC) for one or more protocols • Exhibits leadership role in area like UAT, DB testing or process on a large study with guidance.• Conduct data review including query management.• Lead database audit team.• Develop and maintain good communications and working relationships
Krishnendu Sengupta Skills
Krishnendu Sengupta Education Details
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T.John Institute Of Management And ScienceBiotechnology -
Clinical Research And Data Management -
T.John Institute Of Management And ScienceBiotechnology
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Nava Nalanda
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Clinical Research And Data Management
Frequently Asked Questions about Krishnendu Sengupta
What company does Krishnendu Sengupta work for?
Krishnendu Sengupta works for Astrazeneca
What is Krishnendu Sengupta's role at the current company?
Krishnendu Sengupta's current role is Director - Centralized Monitoring AstraZeneca, Innovation, RBM, Process innovation & optimization, Line management, project management, data science, medical review, clinic monitoring and data management.
What is Krishnendu Sengupta's email address?
Krishnendu Sengupta's email address is se****@****ail.com
What schools did Krishnendu Sengupta attend?
Krishnendu Sengupta attended T.john Institute Of Management And Science, University Of Pune, T.john Institute Of Management And Science, Nava Nalanda, University Of Pune.
What skills is Krishnendu Sengupta known for?
Krishnendu Sengupta has skills like Raven Tools, Medical Review, Spotfire, Site Development, Training And Development, Team Management, Teamwork, Data Management, Clinical Data Management, Clinical Research, Data Management Plan, Risk Assessment And Categorization Tool.
Who are Krishnendu Sengupta's colleagues?
Krishnendu Sengupta's colleagues are Sara Alnjdi, Lucie Burns, Jamie Haley (Doughten), Mba, Eduardo Ruivo, Weronika Słomińska, Angèle Mailhou, Mariam Hani.
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Krishnendu Sengupta
Greater Hyderabad Area
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