Back to Job SearchROLE OVERVIEW
An exciting opportunity for a Clinical Data Integrity & System Validation SME to join a leading biopharmaceutical company supporting innovative clinical research initiatives. Our client, a global organization committed to advancing healthcare, is seeking an experienced specialist to ensure GxP system validation, compliance, and readiness within their Digital Technology department. This role is pivotal in maintaining the integrity and security of clinical data, enabling regulatory and clinical activities to operate seamlessly and in full compliance.
This is a remote role, ideally suited for a senior validation expert who thrives in a dynamic, cross-functional environment, and is comfortable working independently alongside internal teams and external collaborators to drive validation projects forward.
KEY DUTIES AND RESPONSIBILITIES
Your duties as the Clinical Data Integrity & System Validation SME will be varied; however, the key duties and responsibilities are as follows:
• Lead and coordinate validation activities for GxP clinical and regulatory systems, including URS, risk assessments, IQ/OQ/PQ, and validation reports.
• Develop and maintain validation documentation and system lifecycle deliverables to ensure compliance with GxP standards.
• Support change management requests, periodic reviews, and system updates across multiple platforms.
• Collaborate proactively with QA, Digital Technology, IT teams, and business SMEs to translate clinical workflows into validation requirements.
• Engage with stakeholders at all levels to ensure alignment regarding business needs and compliance expectations.
• As the SME, you will operate autonomously to manage validation projects from initial requirements through to final validation summaries.
ROLE REQUIREMENTS
To be successful in your application to this exciting role as the Clinical Data Integrity & System Validation SME we are looking to identify the following on your profile and past history:
• A Degree or higher level in a relevant scientific or technical field (e.g., Life Sciences, IT, Clinical Data Management).
• Proven experience of at least 5 years in GxP validation for clinical or regulatory IT systems, with the ability to manage the full CSV lifecycle independently.
• Demonstrable capability to create test strategies, risk assessments, and validation documentation from scratch.
• Excellent communication skills and the ability to work autonomously, engaging directly with stakeholders across functions.
WHAT’S IN IT FOR YOU?
Joining our client offers the opportunity to work on high-impact projects within a global and innovative pharmaceutical environment. You will be part of a collaborative team with a reputation for excellence, gaining exposure to cutting-edge clinical systems and processes, all while enjoying flexible remote working options within European time zones. The role provides a chance to leverage your validation expertise in a senior, autonomous position with significant stakeholder interaction and influence.
Key Words: Validation / GxP / Clinical Data / System Validation / CSV / Regulatory Compliance / Life Sciences / Clinical Systems / Remote Working / Stakeholder Engagement / #LI-DNI
"Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career".
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
