Process Excellence

Company Description

Cliantha Research is a full-service Clinical Research Organization (CRO) providing comprehensive services across Early Phase, Late Phase, Respiratory, Dermatology, and more. With a presence in four countries, advanced clinical sites, and bio-analytical laboratories, Cliantha supports end-to-end clinical development for pharmaceutical, biotech, and healthcare companies. Headquartered in Ahmedabad, Cliantha has over 1,000 professionals working globally, with locations in India, the USA, Canada, and Europe. The company holds accreditations from major regulators, including USFDA, EMA, Health Canada, and more, ensuring excellence and compliance across its offerings.

Role Description

This is a full-time, on-site Process Excellence role located in Ahmedabad. The Process Excellence professional will be responsible for analyzing and improving business processes, developing and overseeing process enhancement strategies, providing training and support to relevant teams, and ensuring exceptional customer service standards.

Brief Job Profile :

• Process Excellence IT Specialist who will help elevate process excellence across our clinical research ecosystem. Gap analysis of IT infrastructure and IT related processes. To connect all Clinical Research operations and IT, enabling streamlined processes, smarter use of technology, and strong regulatory compliance across all research activities. Lean Six Sigma thinking and a continuous improvement mindset to support Cliantha s commitment to quality and integrity.

Other Technical /Specific requirements: :

• 4-6 years of Experience with EDC, CTMS, and clinical data platforms used in CRO environments is preferred.
• Ensure technology solutions align with Cliantha s multi country operational setup and regulatory requirements.
• Excellent communication and stakeholder management abilities.

Must-have Skills :

• Ability to solve moderate to complex problems,Process Analysis,QMS Processes,Process-Related Tracker,21CFR Part11/GAMP5/EUAnnex 11,IT compliance risk management.
• Ability to manage and coordinate multiple projects, take project ownership, and coordinate cross-functional department and communicate with sponsor effectively.
• Adherence to ICH,GCP guideline, USFDA, EU and other Regulatory Guidelines.
• Ability to work as a team player as well as an individual with excellent communication skills.
• Ability to prioritize,Ability to communicate with efficacy,Basic knowledge of Microsoft & utilities,Streamlining Process,Information Technology Infrastructure.
• Accurate and Timely Processing,Application Performance Analysis & Improvement.
• Ability to interpret complex clinical data,Analytical problem solving,Audit Tracking tools and CAPA System.