The Clinical Automation Testing Expert will lead the strategy, design, and implementation of automation testing frameworks for clinical technology platforms, with a primary focus on RTSM (Randomization and Trial Supply Management) products. The role is responsible for ensuring comprehensive test coverage, efficiency, and the creation of structured, traceable, and auditable testing evidence that meets sponsor expectations and global regulatory requirements. Working closely with engineering, QA, clinical operations, and business stakeholders, the role will help define quality standards and best practices that support compliant and high-quality clinical product development.
In this position, the Clinical Automation Testing Expert will serve as a subject-matter authority for automation and validation, providing guidance during audits and inspections and ensuring all testing activities are reproducible and compliant with FDA, EMA, and GxP standards. The role also involves mentoring testing teams, continuously improving automation processes, and driving innovation to accelerate testing cycles without compromising quality. This is a highly collaborative role requiring strong leadership, attention to detail, and the ability to operate effectively across multiple clinical applications and projects.
Key Responsibilities
Lead the design and implementation of automation testing frameworks for clinical (RTSM) products, ensuring comprehensive test coverage and efficiency.
Direct the team in developing structured and auditable testing documentation and evidence to meet sponsor and regulatory compliance requirements.
Collaborate with cross-functional teams to define quality standards and best practices for automated testing in clinical product development.
Continuously assess and improve automation processes to accelerate testing cycles while maintaining the highest product quality.
Provide expert guidance during audits and inspections, ensuring all testing activities are traceable, reproducible, and meet industry standards.
Required Skills and Experience
Extensive experience in automation testing, preferably within clinical trials or RTSM (Randomization and Trial Supply Management) products.
Strong understanding of regulatory requirements (e.g., FDA, EMA, GxP) for software validation in clinical environments.
Proficiency in automation tools and scripting languages relevant to clinical product testing.
Proven ability to design and maintain traceable and auditable testing evidence.
Excellent written and verbal communication skills.
Desired Attributes
Demonstrated leadership and mentoring abilities within testing teams.
Detail-oriented with a focus on quality and compliance.
Collaborative mindset and willingness to share knowledge.
Adaptable and comfortable working across diverse clinical applications and business groups.
Proactive attitude towards learning and embracing new technologies.
Strong organisational skills and attention to detail.
The Clinical Automation Testing Expert will work closely with cross-functional teams, including developers, testers, clinical operations, and business stakeholders. The role offers exposure to a wide range of clinical applications and requires flexibility to support multiple project requirements. Our company fosters an inclusive environment where innovation, compliance, and teamwork are highly valued.
