Hardik Patel

Highly skilled Clinical Research Process Excellence Manager with 14+ years of global experience in clinical research, BA/BE studies, quality management, and process improvement. Proven track record in QMS implementation, Lean Six Sigma methodologies, training, and regulatory compliance (USFDA, EU, WHO, MHRA, ANVISA). Adept at driving operational efficiency, software validation, and cross-functional training.

Recognized leader with strong ability to align processes with international standards for global CRO operations.

Process Excellence Manager - Cliantha Research Ltd. - Ahmedabad, India

(2025-05)

• Lead process optimization and continuous improvement initiatives using Lean Six Sigma.
• Implement efficient workflows ensuring GCP/GLP compliance across global sites.
• Drive cultural transformation towards quality, innovation, and regulatory readiness.

Sr. Manager (Lead SME) Training & Development - Veeda Clinical Research Ltd. - Ahmedabad, India

(2024-02 - 2025-04)

• Spearheaded QMS harmonization across multiple locations.
• Delivered organization-wide training on GCP, GLP, GAMP.
• Managed large-scale projects: Annual GCP Workshop 2025, regulatory compliance revamp, software integration.

Training Manager / Assistant Manager / Sr. Executive - Cliantha Research Ltd. - Ahmedabad, India

(2018-03 - 2024-02)

• Conducted 175+ technical trainings on BA/BE, clinical research, and compliance.
• Implemented Training Information Management System.
• Strengthened onboarding and SOP compliance programs.

Sr. Research Associate / Research Associate - Lambda Therapeutic Research Ltd. - Ahmedabad, India

(2012 - 2018)

• Led method validation, bioanalytical analysis, and GLP compliance using LC-MS/MS and advanced instrumentation.

M.Pharm - Forensic Pharmacy - Gujarat Forensic Sciences University (2012)

B.Pharm - Rajiv Gandhi University of Health Sciences (2008)