Krishnendu Sengupta Email & Phone Number

Bengaluru, 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

Bangaon 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.

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 • 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.

Bangalore

• 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.

Bengaluru 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.

• 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

• 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.

Bengaluru 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

Responsibilities 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

Responsibilities 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

Master'S Degree, Biotechnology

Post Graduate Diploma, Clinical Research And Data Management

Bachelor Of Science (Bsc), Biotechnology

Education record

Post Graduation Diploma, Clinical Research And Data Management