Dilip Reddy
Project Manager - RTSM
Bangalore,KA
Summary
Versatile and accomplished professional with over 15 years of diverse experience spanning clinical research, end-user support services, quality control, and customer relationship management. Proven expertise in managing global RTSM systems, executing software quality assurance, and leading cross-functional teams in high-pressure environments. Demonstrated ability to drive operational efficiency, ensure regulatory compliance, and deliver end-user solutions in clinical trials and financial service domains. Adept at mentoring teams, streamlining service delivery workflows, and enhancing user satisfaction.
Overview
17
17
years of professional experience
2
2
Certifications
Work History
Project Manager, Mentor RTSM
SITERO
08.2023 - 06.2025
- Led end-to-end delivery of RTSM systems for over 15 global clinical trials, enhancing randomization processes and supply chain management for pharmaceutical clients.
- Collaborated with cross-functional teams, including clinical operations, data management, and IT, to ensure seamless integration of RTSM solutions with EDC and IVRS systems.
- Implemented Agile methodologies to accelerate project timelines, resulting in a 20% reduction in delivery time for RTSM system deployments.
- Managed vendor relationships, ensuring compliance with regulatory standards and achieving a 98% on-time delivery rate for trial supplies.
- Conducted risk assessments and developed mitigation strategies, reducing supply chain disruptions by 30% during clinical trials.
- Trained and mentored junior project managers and technical support specialists, fostering a culture of continuous improvement and knowledge sharing.
Study Quality Control Analyst
CLARIO
10.2021 - 07.2023
- Execute QC functionalities associated with testing, using approved test plans at various stages during the clinical trials for studies conducted by major pharmaceutical companies.
- In-depth testing of all desired study specifications and data flow in the IRT systems for complete accuracy before the study goes live, or during any interim updates needed.
- Perform quality checks for the data change and MI requests in the system trackers.
- Abide by organizational Standard Operating Procedures (SOPs), Work Instructions (WIs), and Templates.
Senior RTSM Systems Analyst
BIOCLINICA
12.2016 - 09.2021
- Act as an escalation point of contact for team members in resolving critical issues related to subject transactions involved with drug supply changes, and inventory control at the sites.
- Coached and mentored new joiners and non-domain-experienced team members in all deliverables of the RTSM functions.
- Conduct meetings and interact with the internal and external study teams to update the study-specific changes to the live environment.
- Performed call quality and incident reviews every week, along with retrieving CSAT scores, and shared them with the management.
- Update/modify all Sponsor-approved data points in the study, which include subjects’ data, kits, and Lots information of the study trials via Data Change and Parameter Change Forms received from clinical sites.
- Create, modify, and revoke user account accesses to the trial, and amend site details in the end user’s system as per the approved Sponsor requests.
- Perform quality checks for the user accounts and site requests submitted, ensuring zero scope for errors in the clinical data.
Client Support Specialist
PAREXEL International (INDIA) Private Limited
10.2013 - 05.2015
- Delivered Tier 1 & Tier 2 support to clients in a regulated clinical trials environment, handling high volumes of inquiries and resolving complex issues efficiently.
- Maintained client satisfaction through responsive communication, escalation management, and detailed service tracking in various systems like RTSM Clinphone, EDC Data Labs, etc.
- Applied analytical and organizational skills to support operational excellence and customer retention.
- Ensure to deliver the best process standards of quality, compliance, and productivity.
Process Developer (JC Penney Collections)
GE Global Servicing Private Limited
11.2011 - 02.2013
Process Expert (AR Operations, Global Financial Services)
Dell International Services
01.2008 - 08.2010
Customer Support Expert for the American Business Unit Customer Care
Dell International Services
03.2007 - 12.2007
Team Lead - Operations
Global Info Solutions
09.2005 - 02.2007
Team Lead - Operations
Omni Voice Technologies
11.2003 - 08.2005
Education
B.Tech - EEE
All India Institute of Technology
Skills
Clinical Trial Support Operations
Project Planning and Budgeting
End User Support & Services Management
Incident & Escalation Management
Risk Assessment and Mitigation
Quality Assurance and Monitoring
Customer Service and Client Support
Certification
GCP and ICH Guidelines Certification (Internal at Sitero)
Timeline
Project Manager, Mentor RTSM
SITERO
08.2023 - 06.2025
Study Quality Control Analyst
CLARIO
10.2021 - 07.2023
Senior RTSM Systems Analyst
BIOCLINICA
12.2016 - 09.2021
Client Support Specialist
PAREXEL International (INDIA) Private Limited
10.2013 - 05.2015
Process Developer (JC Penney Collections)
GE Global Servicing Private Limited
11.2011 - 02.2013
Process Expert (AR Operations, Global Financial Services)
Dell International Services
01.2008 - 08.2010
Customer Support Expert for the American Business Unit Customer Care
Dell International Services
03.2007 - 12.2007
Team Lead - Operations
Global Info Solutions
09.2005 - 02.2007
Team Lead - Operations
Omni Voice Technologies
11.2003 - 08.2005
B.Tech - EEE
All India Institute of Technology