System Specialist

The post-holder will specifically support systems and processes, focusing on the tools and workflows that enable scientific and regulatory document creation, review, and submission. The role operates at the intersection of clinical science, regulatory compliance, and information technology, partnering with process owners, quality teams, and external vendors to govern and improve the GSC system portfolio.

Position Summary

The System Specialist will work within the Clinical Trial team, supporting systems and processes that relate to Global Scientific Communications. The successful candidate will bring experience in system ownership, compliance documentation, and stakeholder engagement, and will contribute to the implementation, improvement, and ongoing governance of tools and processes within the GSC portfolio.

Primary Responsibilities:

System Ownership

• Maintain and grow expertise in clinical information systems, business strategies, processes, and technology as they relate to clinical development.

• Hold system ownership and stewardship of tools that enable scientific and regulatory document creation.

• Define, lead, and execute implementation plans to deliver on technology strategies and improvements.

• Work with vendors to improve customer experience and efficiency.

Compliance and Quality

• Maintain and create compliance and quality documentation for systems under management, including risk-based validation and tool risk classifications.

• Support internal audits and external inspections.

• Identify project implementation and system execution risks and raise issues appropriately.

Stakeholder Engagement and Delivery

• Partner with process owners, leadership, quality, and technical teams to onboard and integrate systems.

• Identify, monitor, and communicate global customer requirements, both internal and external, as they relate to process and technology performance and improvements.

• Lead and deliver progress reporting activities and system metrics to leadership, process owners, and end users.

• Proficiency in requirements management and process improvement methodologies.

• Actively participate in shared learning across the team.

Minimum Qualifications:

• Bachelor's degree, preferably in science, IT, or a health-related field — or equivalent work experience.

• Experience in medical, quality, clinical drug development, or clinical information flow, preferred.

• Excellent oral and written communication skills; able to communicate clearly and succinctly with team members and leadership.

• Strong problem-solving skills; able to anticipate and recognise problems, diagnose root causes, and take corrective action to prevent recurrence.

• Excellent self-management and organisational skills; able to manage workload, set personal priorities, and adjust as needed.

• Strong interpersonal skills.

• Flexibility to adjust quickly and effectively to frequent change and altered priorities.

Additional Preferences:

• Advanced degree in a relevant field.

• Background in systems support within a clinical or regulated environment.

• Knowledge of regulatory and quality requirements governing clinical development.

• Knowledge of GxP requirements, preferred.

• Experience in technical writing for compliance and quality documentation.

• Experience in clinical trial systems as well as current and evolving technologies to support clinical development.

• Knowledge and/or experience in project management and organisational change with internal and external parties, including vendors, industry experts, and related organisations.

• Good leadership skills and strong business insight.

• Demonstrated strength in logical thought, problem-solving ability, and critical thinking.

• Ability to communicate and influence across functional boundaries.

• Ability and experience in building consensus and resolving conflict to drive progress.

• Flexibility in approach and/or high learning agility.

• Ability to adjust to unexpected business opportunities while also being a catalyst for change.