AMEYA PRABHU
Hyderabad
Summary
PMP-certified Clinical Project Management professional with 9+ years of experience leading clinical operations across global studies. Expertise in clinical trial management, project planning, budget oversight, resource allocation, risk management, quality assurance, and regulatory compliance. Recognized for building high-performing teams, optimizing processes, and partnering with stakeholders and vendors to deliver study milestones efficiently while maintaining the highest quality standards.
Overview
1
1
Certification
9
9
years of professional experience
Work History
R&D Project Manager
Sanofi
10.2025 - Current
- Identifies issues to be raised with Project Leader and proposes solutions and mitigation plans.
- Acts as key connector between different functional interfaces: between sub-workstreams, team members and other parts of the organization.
- Communicates project vision as needed and establishes trust within the project team and functional departments.
- Lead regular study team meetings and governance meetings and communicate project status to stakeholders.
- Ensures communication to all stakeholders, including regions, functions and platforms as needed. This includes project reports and timely alerts.
- Lead the planning and execution of clinical trials from study start-up to database lock/close-out.
- Develop and maintain clinical trial timelines, milestones, budgets, and resource plans.
- Ensures execution of project plan and roadmap within expected timelines
- Ensures that team members are aligned to deliver on project plans
- Manages stakeholders by ensuring communication to departmental management on issues related to their deliverables and/or responsibilities.
- Actively contributes to the creation of presentations to Sponsors, management committees, and others as appropriate.
- Completes the project trackers/ PM Tools on a regular, timely and consistent basis.
- (Co-) leads project team meetings in alignment with the Project Leader.
- Supports and/or leads sub-team meetings as appropriate case-by-case.
- Ensures implementation of initiatives and solutions across R&D
- Monitor recruitment, site activation, monitoring activities, data cleaning, query resolution, and study milestones.
- Manage CROs, vendors, investigators, and external partners.
- Monitor recruitment, site activation, monitoring activities, data cleaning, query resolution, and study milestones.
Associate Manager, Clinical Operations
IQVIA RDS Pvt. Ltd.
05.2024 - 10.2025
- Spearheading the recruitment and onboarding process for new team members, including candidate evaluations and participation in interviews.
- Conducting comprehensive onboarding training sessions in collaboration with HR and Learning & Development Teams to ensure smooth integration of new staff.
- WORK EXPERIENCE
- Ensuring all staff are equipped with the necessary resources, system access, and training to effectively perform their roles.
- Supervising the execution of training plans, review and update Standard Operating Procedures (SOPs), and mentor staff through structured training experiences.
- Allocating resources across projects, assigning staff based on their expertise, experience, and training.
- Monitoring and assessing the quality of work delivered by assigned staff through regular performance reviews and evaluations.
- Identifying potential quality risks and issues, developing and implementing corrective action plans to address performance gaps.
- Managing project schedules, ensuring timely updates on key milestones and coordinating with Project Leaders (PL) for related discussions.
- Supporting the risk and issue management process, actively identifying and addressing project risks to maintain timelines and deliverables.
- Coordinating project finances, including the preparation of Estimates at Completion (EAC), tracking monthly expenses, managing invoices, and reconciling budgets.
- Engaged in ensuring compliance with Vendor and Purchase Order (PO) Management Processes, while implementing and maintaining baseline and change control procedures.
Business Process Lead, Clinical Operations
Tata Consultancy Services
08.2022 - 05.2024
- Ensured clinical trial documentation adhered to established standards, work instructions, and ICH/GCP guidelines, while acting as the primary contact for audits and inspections.
- Directed global study teams by providing expertise to achieve study deliverables with high quality and within defined timelines.
- Designed and managed performance dashboards to track project metrics, analyze event triggers/alerts, and recommended appropriate follow-ups to Project Leaders (PL).
- Coordinated project schedules, providing regular updates on key milestones and supported PLs during critical project calls.
- Prepared formal correspondence, including meeting minutes, for project teams and stakeholders, thus ensuring clear communication across all levels.
- Organized and facilitated internal project team and client meetings, while ensuring alignment on objectives, timelines, and deliverables.
- Created detailed project status reports and presentations for internal and client-facing meetings to monitor progress and performance.
- Managed core file reviews and supported audits, drove compliance with electronic Trial Master File (eTMF) requirements focused on completeness, timeliness, and quality.
- Directed project-specific eTraining activities, ensured team members completed required training modules and maintained compliance.
Senior Clinical Quality Specialist
Teva Pharmaceuticals
12.2020 - 08.2022
- Managed product quality complaints for the U.S. market, acted as the primary liaison between manufacturing sites and healthcare professionals.
- Tracked defective return samples, while ensuring effective communication and resolution of quality issues.
- Updated process-related documentation to reflect current practices and regulatory requirements.
- Prepared documentation for credit, replacement, and related quality reports.
- Developed presentations on assigned products to communicate key quality insights to internal stakeholders.
- Delivered training sessions to new employees, focusing on processes, Standard Operating Procedures (SOPs), and quality standards.
- Coordinated the closure of complaints within the TrackWise System, while ensuring compliance with regulatory timelines.
- Coordinated with the Pharmacovigilance Department, compiled communications from various departments for weekly reporting.
- Monitored and compiled notifications from third-party manufacturing and packaging sites, while ensuring regulatory compliance.
- Created lot numbers in SAP for quality and non-product complaints based on departmental requests.
- Evaluated and closed complaints effectively, while ensuring all quality issues were documented, investigated, and resolved appropriately.
- Maintained oversight of Annual Product Quality Reviews (APQRs) as per FDA regulations, prepared SOPs and relevant documentation.
- Reviewed and updated Work Instructions (WIs) and managed data updates in SAP to maintain accuracy and compliance with Teva’s quality standards.
Senior Clinical Trial Assistant
IQVIA RDS Pvt. Ltd.
11.2017 - 12.2020
- Managed document and activity tracking within the Clinical Trial Management System (CTMS) to support trial operations.
- Analyzed the review, compilation, and distribution of project documents and materials across study teams.
- Processed and tracked study-specific documents, thus ensuring timely and accurate documentation.
- Conducted central file reviews and documented findings to support compliance and quality assurance efforts.
- Organized and maintained correspondence files and other project-related records for easy access and reference.
- Analyzed and reconciled project documents, metrics, and findings reports within defined timelines to support project management.
- Assisted in resolving documentation-related issues and clarifications during audits and inspections.
- Engaged in translation activities and quality control checks for translated materials as required.
- Attended Project Launch and Kick-off meetings, captured key discussions and action items in meeting minutes.
Education
Bachelor of Pharmacy -
University of Mumbai
01.2016
Skills
- Clinical Trial Management
- Clinical Project Management
- Study Start-Up & Closeout
- Cross-Functional Leadership
- Project Planning & Execution
- Risk & Issue Management
- Budget Forecasting & Financial Oversight
- Resource Allocation & Capacity Planning
- Vendor & CRO Management
- Stakeholder Management
- ICH-GCP & Regulatory Compliance
- Quality Management & CAPA
- Audit & Inspection Readiness
- Clinical Operations Oversight
- Timeline & Milestone Management
- Process Improvement & Operational Excellence
- Team Leadership & Staff Development
- CTMS & eTMF Management
- KPI Monitoring & Performance Reporting
- Change Management
- Strategic Planning
- Global Study Coordination
- Documentation & Trial Master File Management
- Protocol Implementation & Study Conduct
- Problem Solving & Decision Making
Certification
- Certified Project Management Professional (PMP), Project Management Institute, February 2024, 02/01/24
- Certified Lean Six Sigma Green Belt and Black Belt, The American Society of Quality (ASQ)
- Certified Lean Practitioner and Facilitator MOOC
Accomplishments
- Contributed to client audits, ensured strict compliance with industry regulations, and identified process improvements to enhance operational efficiency.
- Led a team of 25 during a sponsor audit at IQVIA RDS in 2019, thus achieving a flawless outcome with zero audit findings.
- Drove process quality optimization improved performance from 59% to 86% within the first quarter of 2020.
- Designed a comprehensive CAPA template incorporated the 5 WHYs, Pareto analysis, and Cause-andEffect methodologies to identify root causes and implement targeted corrective actions.
- Successfully managed project timelines under tight schedules and team absences due to medical leaves by applying schedule compression techniques (crashing and fast-tracking), thereby ensuring on-time delivery of clinical study milestones, and enhancing stakeholder satisfaction.
Phone Numbers
- +91 9730412523
- +91 8010345861
Languages
- English
- Hindi
- Marathi
- French (Beginner)
License
Licensed Pharmacy Professional affiliated to the Maharashtra Pharmacy Council of India and Pharmacy Council of India, Maharashtra Pharmacy Council of India, Pharmacy Council of India
Timeline
R&D Project Manager
Sanofi
10.2025 - Current
Associate Manager, Clinical Operations
IQVIA RDS Pvt. Ltd.
05.2024 - 10.2025
Business Process Lead, Clinical Operations
Tata Consultancy Services
08.2022 - 05.2024
Senior Clinical Quality Specialist
Teva Pharmaceuticals
12.2020 - 08.2022
Senior Clinical Trial Assistant
IQVIA RDS Pvt. Ltd.
11.2017 - 12.2020
Bachelor of Pharmacy -
University of Mumbai