Clinical Systems Validation Specialist Full Time

Emerald Clinical Trials is a global leader in clinical research, partnering with over 160 biotech companies and 15 of the world’s top 20pharmaceutical firms. Headquartered in Singapore, we combine scientific excellence with operational expertise to deliver end-to-end clinical trial solutions across all phases, offering Phase I-IV and real-world studies.

With over 25 years of experience and a world-renowned focus in renal research, Emerald Clinical has helped drive medical breakthroughs through deep scientific insight, flawless execution, and an unwavering commitment to quality.

Global Expertise. Local Insight. Real Impact.

Emerald Clinical is where science, speed, and strategy come together to transform healthcare. For over 25 years, we have led the way in clinical research, combining global reach with deep Asia-Pacific expertise and unparalleled local insight to deliver smarter trials and stronger outcomes.

Our 800+ employees that span across Asia-Pacific, Europe, and the Americas are embedded in communities worldwide. We drive faster recruitment, deeper patient engagement, and meaningful results that move medicine forward.

About The Role

The Clinical Systems Validation Specialist is responsible to ensure the compliance and effectiveness of GxP computer systems within the organization. The GxP System Validation Specialist will achieve this by:

Your Responsibilities

• Managing the GxP system validation lifecycle: This involves overseeing all stages of validation, from planning to ongoing maintenance and integrations.
• Developing testing/validation plans executing the tests confirming system meets GC requirement: This ensures a systematic approach to testing and verifying system functionality.
• Maintaining validation documentation: Proper documentation is crucial to demonstrate compliance and audit readiness.
• Mitigating system risks: The specialist proactively identifies potential issues and implements solutions to safeguard data integrity and system performance.
• Staying current with GxP regulations: Adapting to evolving regulations ensures the validation process remains effective.

Training, Quality and Compliance

• Manage all aspects of the GxP system validation lifecycle, including planning, design qualification (DQ), installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and revalidation.
• Develop and execute comprehensive validation plans and test protocols to ensure thorough system testing.
• Perform gap analysis to identify any deviations from GxP requirements.
• Prepare and maintain all validation documentation, including test plans, test scripts, test reports, and validation summaries.
• Conduct risk assessments and develop mitigation strategies to address potential system vulnerabilities.
• Liaise with internal stakeholders (e.g., IT, Quality Assurance) and external vendors to ensure smooth execution of the validation process.
• Stay up-to-date on the latest GxP regulations and industry best practices for system validation.
• Participate in continuous improvement initiatives to optimize the validation process.

Customer Focus and Teamwork

• Attend and actively participate in Emerald Clinical meetings and other internal meetings and activities as required
• Provide input to systems, tools and processes to support continuous improvement
• Share knowledge with others, to facilitate learning and development across the organisation

Work Health and Safety

• Comply with Work Health & Safety (WH&S) legislation and operate in accordance with established organisational WH&S practice and procedures
• Promote and contribute to a safe, secure environment for staff and visitors

About You

• Bachelor’s degree in a relevant discipline such as Life Sciences, Computer Science, Engineering, Information Technology, or a related field.
• Advanced degree (Master’s or equivalent) is desirable but not mandatory, based on role complexity and system criticality.
• Formal training in GxP regulations and computerized system validation principles (for example GAMP 5, GCP, 21 CFR Part 11, Annex 11).
• Ongoing continuing education to remain current with evolving regulatory expectations, validation methodologies, and industry best practices.
• Minimum of 4-5 years of hands-on experience in GxP system validation.
• Prior experience with Electronic Data Capture (EDC) application validation is highly preferred.
• Strong understanding of GxP regulations (e.g., GAMP 5 and GCP) and their application to computerized systems.
• Excellent knowledge of validation methodologies (IQ, OQ, PQ, revalidation).
• Proven ability to develop and execute comprehensive validation plans and hands on system testing using UAT test scripts.
• Excellent documentation skills with a strong attention to detail.
• Ability to manage and prioritize multiple tasks simultaneously.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.

Why Join Us?

At our core, Emerald Clinical Trials is committed to transforming clinical research by putting people first—both patients and our employees. By joining our team, you’ll be part of a global network of passionate professionals working together to deliver better research and outcomes for millions worldwide.

Here’s What Makes Us Stand Out

• Purpose-Driven Work: You’ll contribute to clinical trials that genuinely improve lives, with a focus on therapies in renal, cardiometabolic, and oncology.
• Global Reach, Local Expertise: Our teams connect with local communities, building trust and meaningful engagement for every trial.
• Collaboration and Innovation: Work in a culture that values diverse perspectives and creative solutions to solve global health challenges.

What We Offer

We understand that great work happens when people feel valued and supported. That’s why we provide:

• Competitive Compensation: A tailored salary and benefits package to reflect your skills and experience.
• Flexibility: Enjoy hybrid or remote working arrangements, depending on your location and role.
• Career Growth: Access to a wealth of learning opportunities and a global network of scientific leaders to help you grow and develop in your role.
• Employee Wellbeing: Participate in programs and initiatives designed to promote work-life balance, health, and team connection, including global engagement surveys, recognition programs, and team-building events.
• Global Opportunities: Be part of a company with international reach, offering you exposure to diverse projects and clients.

Interested? Apply now and help us achieve our mission to improve the health of millions worldwide.

We are an equal-opportunity employer and encourage applications from all qualified candidates.