Nadanakumar Ganesan
Tampa,FL
Summary
Well-qualified in Life Science Industry in various phases of Clinical Trial and Clinical Design implementation and Subject Matter Expert responsible for Clinical Data Management products/tools like iMedidata, Medidata Rave, Shared Investigator Platform, Oracle Clinical/TMS, CTMS and Clinical Study Design & Analysis Products for Modeling and Simulations . Skilled and pragmatic with strong attention to detail and methodical approach. Prepared to offer 13 years of experience to fast-paced position with room for advancement.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Clinical Technical Project Manager
Akshaya Inc (Genentech Inc.,)
03.2022 - Current
- Subject Matter Expert of EDC and Clinical Systems, Review technical specifications and orchestrate efficient large-scale software deployments to optimize performance, grow automation, and ensure quality and regulatory compliance
- Implemented cutting-edge technologies to optimize workflow efficiency and enhance overall operational performance on key initiatives like Smart Query, Study Build Automation, PDF Generation BOTs, data point mitigation, CTMS-Veeva Vault Integration
- Collaborated closely with cross-functional teams to design and implement enterprise-wide scalable robust IT solutions to meet client requirements of integrated systems and clinical systems
- Successfully delivered multiple high-profile projects on time, ensuring client satisfaction and fostering long-term relationships
- Established culture of continuous improvement, empowering employees to identify areas for optimization and implement innovative solutions
- Initiated change management strategies that effectively addressed customer concerns while driving forward organizational transformation efforts
- Reduced project costs with diligent budget management and resource allocation strategies, enabling completion of projects under budget
- Identified risks early in project lifecycle, developing mitigation plans to prevent schedule delays or cost overruns
- Established clear lines of communication between stakeholders by creating detailed status updates that kept everyone apprised of critical milestones throughout each stage of project
- Conducted performance evaluations and provided constructive feedback to team members, promoting professional growth and development
Clinical Product Specialist
Cognizant Technology Solutions (Amgen Inc.,)
04.2016 - 03.2022
- Liaised with clients, CROs to develop deep understanding of business needs and current market landscape, including development of RFPs
- Primary Point of Contact for CDM Products/Applications like Oracle Clinical/TMS 4.5.1, Medidata Rave, iMedidata, Cloud Admin, CTMS, DEVODS, Shared Investigator Platform, Clinical Study Design & Analysis Products for Modeling and Simulations
- Consulted with product development teams to enhance products based on customer interest data
- Identified downstream effects of business requirements on associated applications.
- Responsible for technical and functional feasibility analysis of project requirements and enhancements and provide development, resource planning, and cost estimation.
- Expand or modify system to serve new purposes or improve work flow
- Design, develop, validate clinical trial data and configuration of EDC systems using CDM products/applications and Clinical Study Design & Analysis Products for Modeling and Simulations per client's requirements
- Performed first hand analysis of production issues and managed production support services engagement, Design and develop logical and physical data models according to business intelligence principles
- Strategy development and executional oversight on key initiatives, Vendor Relationship Management, Resource Planning, Business Performance Management (KPIs, KQIs), Business Process Re-Engineering
- Developed product documentation to communicate and align key components of upcoming features and products to internal teams
- Demonstrated capabilities managing large scale, enterprise software requirements definition, designs and implementations in global 24/7
- Coordinated innovative strategies to accomplish marketing objectives and boost long-term profitability
- Documented user stories, specifications and product features into detailed work order to communicate across teams and build mandatory requirements
- Thrived in fast-paced, highly-adept team developed and prioritized product features and build product roadmap
- Saved $300K by implementing cost-saving initiatives that addressed long-standing problems
- Lead and coordinate Sprint Planning and review, Daily Scrums
- Coordinated design meetings and decisions across cross-functional department and teams
- Established criteria for each milestone within product roadmap as means to measure project progress using agile methodology
- Prioritized roadmap in order to achieve product goals and metrics
- Conceptualized and deployed enhanced product features and optimized implementation for use in marketing strategies
- Assessed vendor products and maintained positive vendor relations
- Promoted high morale and staff retention through dynamic communication, prompt problem resolution, proactive supervisory practices and facilitation of positive work environment
- Enhanced project management skills reviewed internal systems and organized training plans to address areas in need of improvement
- Interviewed and observed clinical end users and business stakeholders to understand workflows, processes, business rules and systems in use
- Managed study team of 20 employees, overseeing hiring, training, and professional growth of employees
- Implemented onboarding for new employees, which enabled each to effectively learn tasks and job duties
Clinical Team Lead
Cognizant Technology Solutions (Amgen Inc.,)
11.2013 - 03.2016
- Provided Strategic leadership for global function of Clinical Data Management and its sub functions- Data Management Services, Database Delivery, Reporting & Analytics
- Accountability for implementation of IRT, eCOA, and other data collection systems.
- Develop standard and Ad-hoc listings to support Data Management and other clinical areas related to EDC studies for data cleaning, data reviewing, and trial monitoring functions
- Managing Study development and reporting with using Medidata Rave and Oracle Inform EDC
- Built and deployed plans, reports, validation procedures and entry processes for data management needs
- Collected, reviewed, and analyzed data from diverse departments for business needs integration for EDC system
- Upheld critical security standards when managing user access actions such as setting up and removing accounts, configuration of elearning
- Wrote work instruction manuals, data capture guidelines and standard operating procedures
- Participated in risk assessment analysis for COTS products to minimize inherent liability in software releases
- Involved in change control process and supported client in post go live activities
EDC Lead Operations
Cognizant Technology Solutions (Novartis)
01.2013 - 10.2013
- Responsibilities included, Design new/modified eCRF, Programmed validation and derivation procedures for clinical studies assigned in Oracle Clinical and reporting solutions for Novartis's Early Development studies
- Wrote User and Functional requirement specifications based on Study Protocol, designed e-CRFs and reports
- Collaborated with Medical Program Coordinators, Data Managers, and Monitors to gather requirements and provided timely solutions such as post-production change requests
- Performed technical review of requirement specifications and provide review comments
- Assigned team with TMS and laboratory Data module Setup in Oracle Clinical
- Performed assigned activities to yield timely and high-Quality deliverable
- Ensured completeness and correctness of all training records and adherence to SOP's, iDMA SWP's, Productivity and Quality targets
- Contributed to Root cause analysis and Process improvements. Adhere to communication and risk/issue escalation pathways
- Prepared good quality document relevant to study development
- Organized knowledge sharing sessions and impart knowledge gathered from earlier studies
EDC Programmer
Cognizant Technology Solutions (Sanofi Pasteur)
04.2011 - 12.2012
- Worked with software development and testing team members to design and develop robust solutions to meet client requirements for functionality, scalability, and performance
- Handled both Inform and Clintrial studies using InForm Architect
- Point of contact for CTA subgroups, performed CTA activities on assigned project in timely manner
- Understand client's requirements and review trial functional specifications
- Presented Protocol Understanding slides of study during Study Kick off Meeting in order to understand client Specification for study and also Interacting with client team on trial timelines, standards and technical study/program related issues (if any)
- Deployed, designed and developed study setup deliverables in client's environment and validated same
- Performed Peer review before study setup activities is delivered to Data Manager/Client
- Involved in Post UAT changes for study setup activities
- Trained team members on Sanofi Pasteur processes, tools, and clinical study as and when required
- Managed overall quality of deliverables including closure of all open QA issues
- Monitored daily deliverables and assured overall quality of deliverables and SLA adherence
- Performed defect analysis for study and identify root cause for issues and escalate it to Project Lead to incorporate preventive actions across studies
- Involved in effort estimation prior to development
Education
Bachelor of Engineering -
Anna University Affiliated
India04.2010
Skills
- Classic Rave, iMedidata, Cloud Admin EDC, EDC Veeva
- Oracle Clinical/TMS, Inform Architect
- Shared Investigator Platform
- CTMS, Veeva Vault, JIRA Systems
- SDTM, Clinical GxP Process
- 21 CFR Part 11, ICH Regulations
- MS SQL Server, SQL Databases
Certification
- Certified in Data Science and Machine Learning: Making Data-Driven Decisions
- Certified Rave Study Builder
- Certified in IT Service Management - EXIN ITILF ITIL®
Timeline
Clinical Technical Project Manager
Akshaya Inc (Genentech Inc.,)
03.2022 - Current
Clinical Product Specialist
Cognizant Technology Solutions (Amgen Inc.,)
04.2016 - 03.2022
Clinical Team Lead
Cognizant Technology Solutions (Amgen Inc.,)
11.2013 - 03.2016
EDC Lead Operations
Cognizant Technology Solutions (Novartis)
01.2013 - 10.2013
EDC Programmer
Cognizant Technology Solutions (Sanofi Pasteur)
04.2011 - 12.2012
Bachelor of Engineering -
Anna University Affiliated
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