Global IT Director - Clinical Research Systems
Global IT Director with proven clinical QMS experience needed by clinical research company. Role involves driving IT strategy and ensuring clinical systems and infrastructure are robust, secure, and compliant. This new leadership role requires a balance of strategic oversight and hands-on expertise, making it ideal for an experienced IT executive passionate about clinical innovation.
Key responsibilities:
- Define and execute the global IT strategy, aligning with business and clinical objectives.
- Oversee clinical IT infrastructure, cybersecurity, and technology-driven innovation.
- Ensure all IT systems and processes comply with Quality Management System (QMS) standards.
- Optimize IT systems to enhance operational efficiency and data security across multiple jurisdictions.
- Lead the implementation and management of Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), Electronic Trial Master Files (eTMF), and other clinical research technologies.
- Ensure IT operations comply with GxP regulations, HIPAA, GDPR, and other data protection laws.
- Manage IT budgets, vendor relationships, and software procurement.
- Provide technical leadership while mentoring and managing global IT teams.
- Foster a customer service-oriented approach for internal teams and clients.
- Report directly to the executive leadership team, influencing key decisions in IT strategy and infrastructure.
Qualifications & Skills:
- Extensive experience in clinical research IT systems (CTMS, EDC, eTMF).
- Strong background in GxP compliance and computer system validation (CSV).
- Proven expertise in IT infrastructure, systems management, and cybersecurity.
- Experience leading IT teams in global, fast-paced environments.
- Deep understanding of data protection laws (HIPAA, GDPR, etc.).
- Strategic thinker with business acumen and transformation leadership skills.
- Strong project management and vendor negotiation experience.
- Excellent communication and stakeholder management skills.
- Project management certifications (PMP, PRINCE2) are a plus.
Reference: 2928408422
Global IT Director - Clinical Research Systems
Posted on Apr 8, 2025 by Lexstra Plc
Global IT Director with proven clinical QMS experience needed by clinical research company. Role involves driving IT strategy and ensuring clinical systems and infrastructure are robust, secure, and compliant. This new leadership role requires a balance of strategic oversight and hands-on expertise, making it ideal for an experienced IT executive passionate about clinical innovation.
Key responsibilities:
- Define and execute the global IT strategy, aligning with business and clinical objectives.
- Oversee clinical IT infrastructure, cybersecurity, and technology-driven innovation.
- Ensure all IT systems and processes comply with Quality Management System (QMS) standards.
- Optimize IT systems to enhance operational efficiency and data security across multiple jurisdictions.
- Lead the implementation and management of Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), Electronic Trial Master Files (eTMF), and other clinical research technologies.
- Ensure IT operations comply with GxP regulations, HIPAA, GDPR, and other data protection laws.
- Manage IT budgets, vendor relationships, and software procurement.
- Provide technical leadership while mentoring and managing global IT teams.
- Foster a customer service-oriented approach for internal teams and clients.
- Report directly to the executive leadership team, influencing key decisions in IT strategy and infrastructure.
Qualifications & Skills:
- Extensive experience in clinical research IT systems (CTMS, EDC, eTMF).
- Strong background in GxP compliance and computer system validation (CSV).
- Proven expertise in IT infrastructure, systems management, and cybersecurity.
- Experience leading IT teams in global, fast-paced environments.
- Deep understanding of data protection laws (HIPAA, GDPR, etc.).
- Strategic thinker with business acumen and transformation leadership skills.
- Strong project management and vendor negotiation experience.
- Excellent communication and stakeholder management skills.
- Project management certifications (PMP, PRINCE2) are a plus.
Reference: 2928408422
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