Shivani Patel
Cary
Summary
Accomplished Global Project Manager with over 5 years of progressive leadership in the CRO industry. Specialized in the full-lifecycle execution of global clinical trials, managing multi-million dollar budgets and cross-functional teams across multiple continents. Expert in Oncology and Immuno-Oncology, with a deep technical background in financial modeling, site budget negotiation, and TMF management. Recognized for maintaining operational continuity during major corporate integrations and consistently hitting milestones for mid-to-large scale biotech sponsors.
Overview
8
8
years of professional experience
Work History
Global Project Manager
ICON
08.2024 - Current
- Successfully navigated the August 2024 KCR acquisition, ensuring 100% continuity of global clinical operations and maintaining seamless communication across newly integrated project teams and sponsors
- Directed comprehensive management of complex global clinical trials from acquisition to completion, ensuring timely execution within scope and budget constraints.
- Orchestrated cross-functional synergy between Clinical Ops, Regulatory and Data Management across multiple countries, synchronizing global workflows to meet critical milestones
- Directed global trial budgets up to $40M, utilizing rolling financial forecasts and resource modeling to prevent budget overruns and align with corporate targets.
- Led the cross-functional transition of legacy study teams into ICON's SOPs, ensuring 100% compliance during the post-acquisition integration phase
- Developed and implemented a Risk-Based Quality Management plans that utilized centralized monitoring to identify a 15% surge in protocol deviations at high-volume sites; by deploying targeted 'for-cause' visits, mitigated systemic data integrity risks and reduced timelines in the lead-up to Database Lock
- Facilitated communication as primary liaison for clients and sponsors, delivering regular updates on project progress, timelines, and potential challenges.
Project Manager
KCR
09.2021 - 08.2024
- Collaborated extensively with study sponsors and internal teams to establish, refine, and implement detailed project plans and operational strategies.
- Overseeing monitoring team performance, ensuring study quality, and mentoring junior CRAs (i.e., Clinical Monitoring Plan, review of MVRs, PDs, metrics)
- Utilized clinical data trend analysis to identify systematic protocol deviation early
- proactively identified "out-of-scope" requests from sponsors, leading the negotiation and execution of Change orders to protect project profitability
- Managed the end-to-end lifecycle of third-party vendors (e.g., central labs, IVRS, EDC), ensuring data transfers remained on the critical path for DBL
- Orchestrated rescue strategies for under-performing sites, implementing patient recruitment and retention plans that accelerated enrollment
- Developed risk assessment and mitigation strategies to proactively manage potential risks and ensure successful project delivery.
- Supporting bid-defense meetings from a PM perspective
- Analyzed project risks and developed mitigation strategies to minimize impact on timelines.
- Developed and executed training programs for new staff, fostering professional growth and competency.
Project Management Analyst
IQVIA
Durham, NC
07.2020 - 08.2021
- Managed monthly Estimate at Completion (EAC) reports, systematically reviewing resource allocation and budgets for a portfolio of clinical trials.
- Assisted in managing program-level and study-level financials, including budget control and supporting the critical billing process.
- Worked closely with functional leads to ensure proper budget allocation and accurate billing for clinical research activities.
- Coordinated internal training sessions for project teams and assisted with site training initiatives.
Sr. Project Specialist
Syneos Health
Durham, NC
05.2019 - 06.2020
- Set up, maintained, and closed out project files and study information (e.g., KPIs, regulatory documents, TMF, AEs/SAEs) across various databases and systems.
- Maintained and distributed study-specific financial reports, site invoices, and investigator payments.
- Supported Project Managers with internal and external meetings, including preparation of materials and distribution of follow-up documentation.
Coverage Trial Analyst
Rush University Medical Center
Chicago, IL
02.2018 - 02.2019
- Utilized Medicare’s Clinical Trial Policy to ensure correct site budget development and compliance.
- Collaborated with clinical nurses to schedule assessments and negotiated site budgets with the Project Manager.
Education
Bachelor of Science (B.S.) - Biology
Loyola University
01-2014
Skills
- Project management
- Laboratory Vendors
- Imaging Vendors
- Veeva Vault Systems (CTMS, IVRS, EDC, eTMF)
- SCOUT, Greenphire
- Medidata Rave, Oracle Inform
- Regulatory Submission Software (CTIS, WCG, Advarra)
- Microsoft Office Suite
- MS Project
- Smartsheet
- PowerBI
- SharePoint
Timeline
Global Project Manager
ICON
08.2024 - Current
Project Manager
KCR
09.2021 - 08.2024
Project Management Analyst
IQVIA
07.2020 - 08.2021
Sr. Project Specialist
Syneos Health
05.2019 - 06.2020
Coverage Trial Analyst
Rush University Medical Center
02.2018 - 02.2019
Bachelor of Science (B.S.) - Biology
Loyola University
THERAPEUTIC EXPERIENCE
- Oncology (09/2021 – Present): Global Studies Solid Tumors (NSCLC II, HCC III, CRC III) and Dose Escalation (Phase 1a/1b)
- Immuno-Oncology: Phase I/II Dose Escalation (1a/1b) and Expansion Cohorts (II), specifically for anti-PD-1/PD-L1 combination therapies
- Internal Medicine (01/2021 – 12/2021): Chronic Asthma and Pulmonary Exacerbation Phase III Global
- CNS (04/2019 – 06/2020): Phase II in Parkinson's Disease and ASD