Balaji B R
Bengaluru
Summary
Dynamic Clinical Project Manager with extensive experience at IQVIA, adept at leading multimillion-dollar projects and managing cross-functional teams. Proven track record in budget management and risk assessment, complemented by strong communication skills. Successfully negotiated vendor contracts and ensured compliance, driving projects to timely completion while maintaining high-quality standards.
Overview
20
20
years of professional experience
1
1
Certification
Work History
Clinical Project Manager
IQVIA
Bengaluru
07.2019 - Current
- Led multiple million-dollar projects across different therapeutic areas/indications through various phases, from startup to closeout.
- Led Bid Defense meetings and Customer kick-off meetings (global and local).
- Ensuring standard project systems and tools are set up and updated continuously.
- Handled Finance Deep Dive calls with the leadership team.
- Handled customer audits.
- Leading/managing cross functional teams and achieving critical milestones across study phase.
- Monitoring team performance against contract and Sponsor expectations according to KPIs.
- Managed change orders from beginning till execution without major comments from Sponsor
- Developing and reviewing study management plans.
- Handled the vendor manager role and was responsible for negotiating vendor contracts.
- Risks, Issues, Quality, and Finance Management.
- Managing compliance for TMF and various study tools.
- Managed close out activities including financial reconciliation and system closure.
- Mentored and provided training to large audiences across different departments on the processes and systems.
Lead Project Management Analyst
IQVIA
Bengaluru
05.2015 - 06.2019
- Updating Project Plans, Schedule, Metrics using QRPM PPM and MS Project
- Monitoring the execution phase to ensure project completion as per the scope of work within the delivery timelines.
- Project Baselining and Change control log
- Risk Management and Assessment using Risk logs and Risk Register, Issue and Lessons Learnt Management
- Stakeholder Management and Assessment
- Project Financial Activities like Revenue Recognition, Backlog Forecasting, Billing Unit
- Review, Billing Worksheet, Budget Changes/Work movement using People soft Financials
- Regularly monitoring the Realization, Operating Surplus, Backlog Variance etc in OBIA (Oracle Business Intelligence Analytics) by analyzing and controlling the factors influencing them to ensure project financial targets are met
- Preparing and Reviewing Project Financial Action Plans monthly to maintain a good financial health for the project
- Verifying Invoices, Co-ordination with Finance team for pending payments from client
- Resource Management using QRPM RM tool
- Developing and reviewing various study level plans
- Project Reporting to Customers.
- Participating in Internal project meetings and client meetings
- Participating in Project Kick off and Close Out meetings, ensuring project close out.
Team Leader
Aris Global
Bengaluru
03.2013 - 04.2015
- • Helping customers in case processing in different workflow activities like “Data Entry, Quality Review, Medical Review, Regulatory Submission” in ARISg.
- Helping customers to understand the ARISg workflow and submitting their cases to FDA, MHRA authorities.
- Helping customers while entering data during case processing.
- Led a team of Development/Test Engineers and successfully handled challenging Development and Testing projects.
- Successfully managed delivery of the complex version of ARISg, agEncoder and Alerts application.
- Involved in creation of Operational Qualification & Performance Qualification scripts and executing test cases in GxP Manager for ARISg and Alerts application.
- Responsible in preparing CAPA for Customers, performing smoke test to verify critical functionality of the application, creating complex SQL queries to create Alerts in the application.
- Providing training to new personnel and admin related activities in ARISg Admin.
- Solely responsible for supporting Customer issues from Offshore during UAT and onsite workshop.
Technical Lead
HCL Technologies
Bengaluru
04.2010 - 02.2013
- As a Technical Lead, led a team of 10 Software/Sr. Software Engineers.
- Responsible for monitoring batches that run on Control M and Wintel servers, and fixing batch errors.
- Recognized for significant improvement of performance and bettering SLA % with respect to SR’s, Incidents within short time.
- Responsible in creating knowledge articles for all the types of issues for all applications.
- Responsible for taking up KT on the new application and handling issues successfully.
- Implemented LEAN processes for my team.
- Implemented new enhancements raised by clients by writing new code and modifying the existing code.
Senior Engineer
Cegedim
Bengaluru
02.2005 - 04.2010
- As a Senior Engineer, handled the tickets raised in CLARIFY and provided timely resolutions.
- Responsible in loading flat files through DATASTAGE and XTELLIGENT.
- Solely responsible for preparing user support/job related documents which was transitioned from US counterparts.
Education
Master of Science - Computer Science
Sikkim Manipal University
Bengaluru11-2012
Bachelor of Science - Computer Science
Bangalore University
Bengaluru07-2005
Skills
Core Competencies
- Project management
- Clinical trial management systems
- Budget management
- Staffing and Resource Management
- Risk management
- Vendor management
- Microsoft Project
- PeopleSoft Financials/Reporting
- Escalation Management
Soft Skills
- Collaborator
- Communicator
- Planner
Accomplishments
- Received Silver award for handling 2 roles during critical milestones and achieving it without any delay
- Received Bronze award for maintaining eTMF metric to green consistently for 2 quarters
- Received Ovation award for Client Focus
- Received “Knowledge bank of team” award
- Received multiple WWD’s awards for my contribution towards project success and mentoring
- Received certificate of appreciation for implementing LEAN process
- Received the Livewire award for being the best performer, received the best performer quarterly award, and received 3 excellent customer satisfaction surveys in 1 year for different customers
Languages
English
First Language
Certification
- Project Management Professional (PMP)
- Certified Scrum Master (CSM)
- Lean Practioner Certified
References
References available upon request.
Timeline
Clinical Project Manager
IQVIA
07.2019 - Current
Lead Project Management Analyst
IQVIA
05.2015 - 06.2019
Team Leader
Aris Global
03.2013 - 04.2015
Technical Lead
HCL Technologies
04.2010 - 02.2013
Senior Engineer
Cegedim
02.2005 - 04.2010
Master of Science - Computer Science
Sikkim Manipal University
Bachelor of Science - Computer Science
Bangalore University
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