Parag Sarve

About Parag Sarve

Clinical Research Professional with 14+ years of experience, including 6+ years in Clinical Project Management, leading global and local trials across Phases II–IV for drugs, vaccines, and medical devices. I manage end-to-end clinical trial project delivery and demonstrated cross-functional team leadership across diverse therapeutic areas including Cardiology, Dermatology, Infectious diseases, Neurology, Oncology, Ophthalmology, Respiratory and Rheumatology.In my current role as a Senior Project Manager, I oversee all aspects of project delivery and strategic planning- Study Start-Up to Close-Out: Protocol development, site activation, and trial close-out activities- Regulatory & Ethics Submissions: Coordination with IRBs/ECs and regulatory authorities- Budget & Finance Management: Forecasting, tracking, and financial oversight- CRO & Vendor Oversight: Selection, onboarding, and performance management- Risk & Quality Management: Implementation of risk-based monitoring and quality control plans- Audit Readiness: Preparation for sponsor audits and regulatory inspections-Team Leadership: Mentoring CTAs, CRAs, and Clinical Leads; resource planning and training- Stakeholder Engagement: Effective communication with sponsors, sites, and internal teamsI have honed my people management and development skills by Training and mentoring CTAs, CRAs, and Clinical Leads. I’ve conducted multiple ICH-GCP and GDP training sessions for clinical research professionals, investigators, and ethics committee members. Additionally, I served as an internal NABH assessor for Clinical Trial Accreditation audits, contributing to quality assurance and regulatory preparedness.My academic background includes a Bachelor’s in Dental Surgery, a Master’s in Clinical Research, and an Executive MBA in Operations. I’ve further strengthened my capabilities through certifications in Project Management and Lean Management.I bring a diverse background, having worked across clinical trial sites, Site Management division and now in a CRO Project Management role in my carrier path. This multi-dimensional experience has equipped me with a comprehensive understanding of clinical trials from all stakeholder perspectives—patients, investigators, sponsors, and regulatory bodies.I am committed to driving innovation, operational excellence, and patient-centric outcomes in clinical research, and I look forward to contributing to impactful healthcare solutions through strategic project leadership.

Experience

1. Clinical Project Manager

   IQVIA

   Oct 2021 — Present · Mumbai, IN

Education

• SPM Junior college

  HSC, General science

  2004 — 2005

• Cranfield University

  Master of Science (MS), Clinical Research

  2010 — 2012

• S P Jain School of Global Management

  Executive MBA , Business Administration, Management and Operations

• MUHS Nashik

  BDS, FORENSIC ODONTOLOGY

  2005 — 2010

Skills

• Quality Assurance
• Clinical Data Management
• Sop Development
• Team Management
• Regulatory Requirements
• Oncology
• Protocol
• Pharmacovigilance
• Quality Control
• Research Ethics
• Ich-Gcp
• Patient Recruitment
• Regulatory Compliance
• Ctms
• Project Management
• Nabh Ethics Committee Acrediation
• CRO
• E Tmf
• U.s. Food and Drug Administration (Fda)
• Medicine
• Record Management
• Gcp
• Nabh
• Clinical Trials
• Record Management
• Pharmaceutical Industry
• Sop
• Publications
• Healthcare
• Neurology
• Digital Marketing
• Informed Consent
• Standard Operating Procedure (Sop)
• Good Clinical Practice (Gcp)
• Hospitals
• Clinical Operations
• General Management
• Big Data Analytics
• Cardiology
• Management