Ajay Saini

About Ajay Saini

Clinical Project / Program Management leader with 17+ years of experience across global Phase clinical development, including Project Lead / Vendor Manager responsibilities, program governance, complex vendor ecosystems, and EMA & US FDA inspection management. Proven ability to integrate clinical operations, quality, regulatory, finance, and vendor oversight within large matrix organizations.Risk and issue oversight, scope and budget management, escalation strategy, inspection readiness, and senior stakeholder decision support. Clinical Operations, Quality Assurance, Regulatory Affairs, Site Activation and Finance ManagementExtensive vendor management and oversight experience, leading global vendors across clinical supply, logistics, laboratories, patient services, and clinical platforms, including Alcura, TecEx, Quantime World, Greenphire, MESM, Clario, Almac, Medidata, Cenduit, Marken, Signant Health, Fisher Clinical Services, and IQVIA Laboratories. Strong background in regulatory inspection leadership, with direct involvement in EMA and US FDA inspections at investigator sites. Therapeutic experience across Infectious Diseases and Vaccines (COVID‑19, Influenza, Rabies, Varicella‑Zoster, Rotavirus, Meningococcal), Oncology (Head & Neck Cancer, Diffuse Large B‑Cell Lymphoma, Peripheral T‑Cell Lymphoma), Respiratory (Asthma), Gastroenterology (Gastroenteritis, Ulcerative Colitis), Cardiovascular (Atrial Fibrillation), Rheumatology (Rheumatoid Arthritis), Neurology (Parkinson’s Disease), and Ophthalmology (Age‑Related Macular Degeneration).Recognized for program‑level judgment, inspection‑focused risk management, financial stewardship, and calm leadership under regulatory scrutiny.

Experience

1. Clinical Project Manager

   IQVIA

   Oct 2024 — Present · Maharashtra, IN

Education

• Kuruksherta University

  Bachelor of Pharmacy - BPharm, Pharmacology, Pharmaceutics, Pharmacology, Medicinal Chemistry

  2003 — 2007

• SVKM's Narsee Monjee Institute of Management Studies (NMIMS)- RECM

  Master of Business Administration - MBA, Business Administration and Management, General

  2019 — 2021

Skills

• English
• Regulatory Affairs
• Clinical Development
• Safety Management
• Clinical Trials
• Meddra
• Gcp
• Inform
• Edc
• Clinical Trial Analysis
• Ctms
• Pharmaceutical Industry
• Sop
• Ich-Gcp
• Patient Recruitment
• Hindi
• Clinical Research
• Gmp
• Time Management
• Pharmaceutics
• Microsoft Office
• Clinical Monitoring
• Clinical Data Management
• Informed Consent
• Irb
• CRO
• Feasibilities
• Clinical Operations
• Regulatory Submissions
• Cardiology
• Informatica