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Nisha Rawal
Clinical Project Manager
Clinical Project Manager
Nisha Rawal is a Clinical Project Manager with 10+ years of experience leading global clinical trials across oncology, rare diseases, infectious diseases, and medical devices. She specializes in study start-up, site activation, TMF oversight, vendor management, and inspection readiness under ICH-GCP, FDA, and EMA frameworks. Skilled in CTMS/eTMF/EDC systems, risk and budget control, and cross-functional leadership, Nisha ensures efficient study delivery across multi-country projects.
FORMERLY AT
Eccentric Clinical Research Organization
LOCATION
Gujarat , India
AVAILABILITY
Full-time
Skills
Audit/Inspection Readiness
CTMS Management
eTMF Management
Inspection Preparation
Medidata CTMS
Project Planning
Regulatory Submissions
Risk & Cost Control
Risk-Based Study Oversight
RWE Project Oversight
Site Activation
Stakeholder/Vendor Coordination
Study Budgeting & Vendor Management
TMF QC & Compliance
TMF QC/Reconciliation
+1 More
Work Experience
Central Monitoring Associate Manager – FSP (APAC & EU)
LabCorp Drug Development / Fortrea
March 2022 – October 2024
- Led study documentation, startup, and site activation activities across global trials. Managed TMF setup, QC, reconciliation, and inspection readiness using Veeva Vault eTMF and Medidata CTMS.
- Supported site qualification/initiation, coordinated with vendors/CROs, and implemented CAPA and quality improvement initiatives.
- Served as SME for documentation standards and TMF compliance, participating in MHRA and internal audits.
TECHNOLOGIES
Veeva Vault eTMF, Medidata CTMS, TMF QC/Reconciliation, Audit/Inspection Readiness
Senior Clinical Project Lead – RWE (APAC)
Technology Health & Big Data (THB)
October 2021 – January 2022
- Directed real-world evidence studies across APAC. Managed vendor selection, timelines, and budgets and oversaw regulatory submissions, site activation, and ICF approvals.
- Led feasibility planning and risk mitigation, improving operational timelines by 25%. Supported supply chain and vendor financial management.
TECHNOLOGIES
Study Budgeting & Vendor Management, Regulatory Submissions, RWE Project Oversight
Clinical Project Associate Lead – APAC Region
Synexus Clinical Research Ltd / PPD
August 2019 – October 2021
- Managed study site activation, monitoring, and training across multiple therapeutic areas including oncology and hematology.
- Led budget oversight, vendor contracts, document QC, and CTMS updates. Implemented performance tracking and risk-based management strategies.
TECHNOLOGIES
CTMS Management, Site Activation, Risk-Based Study Oversight
Clinical Research Monitor / Clinical Trial Assistant
GlaxoSmithKline Pharmaceuticals
March 2018 – June 2019
- Performed remote and on-site monitoring of multi-country trials. Managed TMF documentation, site feasibility, and ethics submissions.
- Ensured protocol compliance and supported issue resolution during trial execution.
TECHNOLOGIES
TMF Management, Monitoring/SDV, Site Feasibility & EC Submissions
Clinical Process Associate (eTMF Specialist)
IQVIA
April 2016 – January 2018
- Maintained TMF accuracy and document quality for multi-country studies.
- Supported inspection readiness and ensured alignment with regulatory documentation standards.
TECHNOLOGIES
TMF QC & Compliance, Inspection Preparation
