SANTOSHI (Sandy) NAIDU

• Company was audited for using OTS Clinical Trial software without necessary validations, hence had to conduct a comprehensive GxP assessment for a critical medical device software system, ensuring alignment with regulatory requirements
• This involved a thorough review of existing processes, documentation, and practices to identify gaps and implement corrective actions, resulting in a seamless regulatory audit.

Assessed Risks: As the project manager, I identified potential risks associated with implementing Rave EDC-Medidata, such as data migration challenges, compatibility issues with existing systems, and regulatory compliance concerns.

Proposed Resolutions: To mitigate these risks, I suggested solutions such as conducting thorough data audits and cleansing before migration, ensuring compatibility testing with other software used in the organization, and collaborating closely with regulatory experts to ensure compliance with industry standards and regulations.

Managed Change Requests: Throughout the implementation process, there were requests for changes, such as customizations to fit specific trial protocols or adjustments to workflows. I evaluated these requests, assessed their impact on the project timeline and budget, and coordinated with the development team to implement them effectively.

Tracked Implementation: I closely monitored the progress of implementing Rave EDC-Medidata, ensuring that each phase of the implementation aligned with the project timeline and budget. This involved coordinating with IT teams, clinical operations teams, and external vendors to address any issues or delays promptly.

Verified Benefits: Once Rave EDC-Medidata was fully implemented, I verified that it delivered the anticipated benefits, such as streamlined trial management processes, improved data quality and integrity, and faster time-to-market for new treatments. This verification process involved analyzing key performance indicators (KPIs), conducting user surveys, and comparing the project outcomes to the initial business case objectives.

I played a crucial role in ensuring the successful implementation of Rave EDC-Medidata by assessing risks, proposing solutions, managing change requests, tracking implementation progress, and verifying the realization of anticipated benefits.

• Spearheaded a cross-functional team to develop a groundbreaking medical device aimed at enhancing patient care and safety

I led the implementation of a state-of-the-art surgical robotic system across multiple hospital facilities. Here's how I managed the project using Smartsheet and leveraged my experience with LIS, EMR, and Middleware:

Managing Projects using Smartsheet:

• Utilized Smartsheet as a comprehensive project management tool to plan, track, and manage all aspects of the surgical robotic system implementation.
• Created detailed project schedules, Gantt charts, and task lists in Smartsheet to outline project milestones, timelines, and resource allocations.
• Assigned tasks to team members, set deadlines, and monitored progress in real-time using Smartsheet's collaborative features.
• Used Smartsheet to facilitate communication and collaboration among project stakeholders, ensuring everyone was aligned and informed throughout the project lifecycle.

LIS, EMR, Middleware Experience:

• Integrated the surgical robotic system with existing Laboratory Information Systems (LIS), Electronic Medical Records (EMR), and Middleware platforms to enable seamless data exchange and interoperability.
• Collaborated with IT teams and vendors to configure interfaces and ensure compatibility between the surgical robotic system and existing healthcare IT infrastructure.
• Conducted extensive testing and validation of data flows between the surgical robotic system and LIS/EMR systems to ensure accuracy, reliability, and compliance with regulatory requirements.

Execution and Monitoring:

• Led cross-functional project teams comprised of surgeons, nurses, IT specialists, biomedical engineers, and vendors to execute the implementation plan.
• Monitored project progress and identified potential risks and issues using Smartsheet's reporting and dashboard features.
• Proactively addressed challenges, adjusted project plans as needed, and communicated updates to stakeholders to keep them informed and engaged.

Project Outcome:

• Successfully deployed the surgical robotic system across all hospital facilities, enhancing surgical precision, reducing procedure times, and improving patient outcomes.
• Achieved seamless integration with LIS, EMR, and Middleware systems, enabling efficient data exchange and documentation within the healthcare ecosystem.
• Leveraged my experience with LIS, EMR, and Middleware to ensure compliance with industry standards and regulations, such as HIPAA and HL7.

Through effective project management using Smartsheet and leveraging my experience with LIS, EMR, and Middleware, I successfully implemented the surgical robotic system, delivering significant value to the healthcare organization and improving patient care in surgical settings.

As the Lead Validation Engineer/ Project Manager (Clinical) . I spearheaded a project to implement a new middleware solution for a large hospital laboratory.

• Led the implementation of a new middleware solution for a laboratory setup (Hospitals)
• Worked closely with cross-functional teams including sales partners, laboratory staff, IT professionals, and internal teams at Beckman Coulter
• Developed a comprehensive project plan outlining key milestones, timelines, and resource requirements
• Tracked progress, addressed potential risks, and ensured alignment with project timelines and quality standards
• Successfully delivered the project on time and within budget
• Seamlessly integrated the new middleware solution into the laboratory's operations
• Strengthened the relationship with the client, positioning BSCI as a trusted partner in healthcare informatics

Participated in pre-installation meetings for a new laboratory automation project at a major healthcare facility.

• Collaborated with Sales partners, Automation Project Managers, Laboratory customers, IT professionals, Networking experts, and internal BCI Teams.
• Aligned project objectives and expectations by facilitating discussions and gathering requirements from all stakeholders.
• Ensured that all parties involved were well-informed and had a clear understanding of the project scope, timelines, and deliverables.
• Proactively addressed any concerns or potential roadblocks raised during the meetings.
• Fostered a collaborative and solution-oriented approach to project planning.
• Implemented feedback gathered from pre-installation meetings to tailor the project plan.
• Ensured alignment with the needs and expectations of all stakeholders involved.
• Developed test plans, protocols and strategies to ensure the highest level of product quality.
• Identified areas of improvement in existing processes related to software development cycle.
• Reviewed and updated quality assurance policies and procedures.

As a Senior Consultant at XYZ Healthcare Solutions, I was tasked with managing the complex project of implementing a new Electronic Health Record (EHR) system for a large hospital network. Here's how I managed the project and created various project artifacts:

Managing Complex Projects:

• Led a multidisciplinary team of healthcare professionals, IT specialists, and vendors throughout the entire project lifecycle.
• Oversaw the planning, execution, and monitoring of the project to ensure its successful completion within scope, budget, and timeline constraints.
• Identified potential risks and issues, such as data migration challenges and workflow disruptions, and developed strategies to mitigate them.

Creating Project Artifacts:

• Developed a comprehensive Communication Plan to ensure effective communication among project stakeholders, including hospital staff, IT teams, and EHR vendors. This plan outlined communication channels, frequency of updates, and key messaging strategies.
• Created a detailed Project Plan outlining project milestones, timelines, resource allocations, and dependencies. This plan served as a roadmap for the project team, guiding their activities and ensuring alignment with project objectives.
• Developed a Risk Management Plan to identify, assess, and mitigate potential risks throughout the project. This plan included strategies for risk identification, risk analysis, risk response planning, and risk monitoring and control.

Through effective project management and the creation of project artifacts such as Communication Plans, Project Plans, and Risk Plans, I ensured the successful completion of the complex EHR implementation project, ultimately contributing to the improvement of healthcare delivery within the hospital network.

In my role as a Clinical Informatics Project Manager at Cook Medical, I led a project to implement a new laboratory information system (LIS) for a regional hospital network. Here's how I managed the project:

• Created project plans, schedules and tracked progress against those plans.

Through effective project management and communication, I successfully implemented the new laboratory information system, enabling the hospital network to improve its clinical operations and deliver better patient care.

• Spearheaded a cross-functional team tasked with the development and launch of a new stent design aimed at improving patient outcomes in cardiovascular interventions.

In my role as a Clinical Informatics Project Manager at BSCI, I led a project to implement a new laboratory information system (LIS) for a regional hospital network. Here's how I managed the project:

Through effective project management and communication, I successfully implemented the new laboratory information system, enabling the hospital network to improve its clinical operations and deliver better patient care.