Neha Srivastava

About Neha Srivastava

As a Clinical Trial Support Manager, I provide strategic leadership in the operational management of clinical studies, ensuring strict adherence to regulatory requirements and organizational standards. My responsibilities encompass comprehensive oversight of study documentation, budget development and monitoring, vendor coordination, and clinical sample logistics. I facilitate critical study meetings and training sessions, implement rigorous quality control processes, and support inspection readiness activities, including preparation for Pre-Approval Inspections. My role is defined by a commitment to operational excellence, cross-functional collaboration, and continuous improvement in clinical research execution.

Experience

1. Clinical Trial Support Manager

   Sanofi

   May 2025 — Present · Hyderabad, IN

   Provide end-to-end operational support for global clinical trials, ensuring the development, review, and maintenance of essential study documents (e.g, SRMP, Monitoring Plan, CTAs, training materials, recruitment plans) in compliance with Sanofi SOPs and regulatory requirements.• Oversee Trial Master File (TMF) and CTMS documentation, ensuring accuracy, completeness, and inspection readiness; manage SharePoint content for study materials.• Support study budget development, quarterly forecasting, and final reconciliation; track vendor payments and collaborate with clinical buyers to resolve invoice discrepancies.• Coordinate and lead internal and external meetings (study teams, vendors, COSCLs), maintain study logs (actions, decisions, risks), and contribute to data review, RBM, and monitoring strategy discussions.• Manage clinical sample logistics in collaboration with translational medicine and lab vendors, ensuring timely tracking, reconciliation, andresolution of operational issues.• Support IMP supply planning, shipment coordination, and reconciliationprocesses.• Participate in audit and Pre-Approval Inspection (PAI) readiness activities, contribute to response development, and implement corrective actions using Sanofi’s inspection-readiness tools.• Train and support Clinical Trial Assistants (CTAs), ensuring adherence to study-specific processes and promoting continuous process improvement.

Education

• GLA University

  Master's of pharmacy (Pharmacology), Pharmaceutical Sciences

  2014 — 2016

• Dr. A.P.J. Abdul Kalam Technical University

  Bachelor of Pharmacy - BPharm

  2010 — 2014