Padmini Sundaramoorthy

Work History

Senior Manager, Software Development

IQVIA RDS Private Ltd

08.2024 - Current

Lead the EDC build and validation teams and Manage Medidata-IQVIA relationship, adopting new products from the Medidata suite, driving innovations, and overseeing organizational change.
Led the development of a company-wide end-to-end (E2E) automation platform, owning all the Edc related processes.
Established strong relationships with clients and stakeholders, ensuring long-term partnerships and repeat business. Represented IQVIA for multiple Bid defenses and Audits
Implemented and developed operational standards, policies and procedures.
Provided strong leadership to enhance team productivity and morale.
Consistently met or exceeded annual performance targets set by senior leadership.
Reduced costs, optimized resource allocation, and improved efficiency in managing projects.
Managed budgets effectively, achieving financial objectives while maintaining strict control over expenditures.
Championed process improvement initiatives that led to significant cost savings without compromising on quality standards.
Coordinated cross-departmental projects to improve product delivery timelines, enhancing customer satisfaction.
Improved team productivity by implementing agile methodologies, reducing project completion times and enhancing collaboration.

Line Manager

IQVIA RDS Private Limited

09.2020 - Current

Project Name: Regeneron and Traditional team
Handled a team of 20+ members which includes Technical designers, Rave Programmers and Validation team leads, participate in recruitment and onboarding of new staff, propose promotion and termination actions
As a Project Manager for Standards creation project for Regeneron, initiated the work order and was involved in Budget planning and Proposal, conducted kick-off meetings with stakeholders and finalized the scope, identified resources and driven weekly status calls, planned the release strategy
As the project Manager of the Fast-track Clean Patient Tracker(CPT) team, Ensured that the core team members are trained in CPT concepts and planned the schedule for CPT implementation and made sure to meet the timelines of the delivery as expected by the Sponsor
As an Operations lead for technical design and Programming team which consists of 25 members, ensured minimum 95% utilization of team members and quality deliverables on time within budget, provided training to team, communications; and milestone deliverables that meet the customer needs
Primary point of contact to the customer for Technical design and programming team
To establish synergy across teams and eliminate the gaps in communication
Allocate studies to Technical designers, programmers and Validation team leads and track the metrics like productivity, quality, defect rate etc
As a RAVE trainer, conduct Rave and custom function training to new resources
Mentor and form a core competent group who can handle the study independently right from study startup till Go-Live

Product SME

Cognizant Technology Solutions

01.2019 - 09.2020

Company Overview: CCMH (SetupSmart) is a Cloud based futuristic MDR based solution which accelerate the study startup and conduct phase right from the protocol creation till submission of datasets
Conceived the idea of building a tool for accelerating study setup and conduct phase
Directing the team in all phases of product development lifecycle which includes requirements gathering, design, and development, SIT, OQ, PQ, UAT and VSR as per GxP validation
As a Rave SME, enabled and supported the team members in learning and understanding the tool requirements, trained the DB experts on Rave Data Model and Webservices
As a Program Manager of cross competent team, ensured the project is following agile principles and creating user stories, providing estimation and tracking the progress in JIRA
Managing the product documentation right from URS, FRS till OQ and UAT logs along with Manuals and training SOPs
Resolving team conflicts, created a rapport within the team and motivated the team leading to an enthusiastic environment
CCMH (SetupSmart) is a Cloud based futuristic MDR based solution which accelerate the study startup and conduct phase right from the protocol creation till submission of datasets

Project Manager

Cognizant Technology Solutions

01.2017 - 09.2020

Project Overview: AbbVie is one of the global leading US based research-driven biopharmaceutical company
Managed eDC team which includes Study build, amendments, testing and Global library management
Project Management which includes Forecasting, Planning and allocation of studies to the teams
Conduct & Manage Rave and Rave related trainings for the Clinical Systems CoE
Setting goals for the team
Conducting Performance evaluation of employees
Conducted brainstorming sessions within the teams to bring out new ideas for innovation
Participated in client visits, Handled ISO and Client audits
AbbVie is one of the global leading US based research-driven biopharmaceutical company

Study Build Manager

Cognizant Technology Solutions

01.2014 - 02.2015

Project Overview: MedImmune was a biologics division of Astrazeneca which handles early phase studies mainly Oncology
Managed Study build team with 10+ resources which includes Study build, amendments, SAS extracts and Reports
Worked on Amendments and performed Migrations, Medidata Coder
MedImmune was a biologics division of Astrazeneca which handles early phase studies mainly Oncology

Reports and Integration Specialist

Cognizant Technology Solutions

01.2012 - 12.2013

Company Overview: Abbott Vascular is a medical devices division of Abbott laboratories
Also worked in customer specific reports like ClinDART, ClinDEV, Device Deficiency reports
Integrated Rave with external systems like IVRS, CTMS using RWS & Batch Uploader
Handled production support tickets
Abbott Vascular is a medical devices division of Abbott laboratories

eDC Study Setup Specialist

Cognizant Technology Solutions

09.2009 - 12.2011

Developed eCRF, Edit checks, SAE Email configurations, custom functions, custom reports using crystal reports
Worked on One-time Custom functions that is required for Amendments for various studies

Summary

Overview

Work History

Senior Manager, Software Development

Line Manager

Product SME

Project Manager

Study Build Manager

Reports and Integration Specialist

eDC Study Setup Specialist

Education

B.Tech - BioMedical Engineering

Skills

Certification

Awards

Timeline

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