The Clinical Systems function provides operational leadership for the clinical business ownership of clinical technology, automation, and clinical reporting across the organisation. At Senior Manager and Manager levels, the role contributes to and helps deliver the clinical roadmap, governance, and adoption of core clinical platforms (including Veeva and Obvio), supports the identification and adoption of clinical AI use cases and contributes to the definition and delivery of standardised, regionalised clinical reporting and KPIs for Clinical Operations. At Lead level, the role provides focused, hands-on operational support within one or more pillars of the function, working under the direction of the Manager or Senior Manager to execute clinical systems and technology activities. A key aspect of this role is the ability to work cross-functionally to project manage clinical systems and technology initiatives from requirements through to adoption, coordinating across QA, IT, Biometrics, PM, Medical, BD/OSL, and Operations/Clinical Services leadership. Given Veeva’s significance as the core clinical platform, this role may be primarily focused on Veeva and may not span all pillars of the function at once, the allocation of responsibilities across pillars will reflect organisational priorities and team structure at any given time. This position supports the translation of clinical business needs into IT-compliant technology solutions, helps remove operational inefficiencies, and drives adoption and compliance across clinical systems and platforms. The Senior / Manager role may have line management responsibility for Specialist, Senior Specialist, and/or Lead team members.
Minimum Qualifications & Experience:
Tertiary qualifications in life sciences or a related field.
Manager: Minimum 5+ years’ experience in clinical operations, process optimisation, clinical systems management, or related functions, with demonstrated ability to coordinate and project manage initiatives across functions.
Experience in clinical trials within a CRO, pharmaceutical, or biotech environment is essential. Candidates must have a solid understanding of clinical operations, including study lifecycle, site management, monitoring, and GCP compliance, and demonstrated experience contributing to process improvement initiatives that have strengthened clinical operational efficiency, quality, or scalability.
Demonstrated experience with, or exposure to, clinical systems such as Veeva and/or Obvio (or equivalent eClinical/CTMS platforms) from a clinical operations/business perspective. Technical configuration/development experience is not required.
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Experience with clinical use cases for AI tools and automation within a clinical operations or clinical quality context is highly desirable. This role partners with IT for technical delivery and does not require AI development expertise.
Experience with clinical KPIs, reporting requirements, and operational dashboards (e.g., Power BI, Excel), and working with IT/BI teams to translate business needs into reporting solutions. Strong proficiency in Microsoft Excel is required, including the ability to work with clinical data sets, build and maintain reports, and use functions such as pivot tables, VLOOKUP/XLOOKUP, and conditional logic to support operational analysis and decision-making. Candidates must demonstrate an understanding of clinical data structures and the ability to perform meaningful reporting on clinical operational metrics.
Strong customer and stakeholder focus, with excellent communication, influencing, and interpersonal skills.
Proven ability to manage multiple priorities, exercise independent judgement, and deliver high-quality outcomes under time pressure, including in ambiguous or newly-defined operating environments.
Responsibilities:
Core responsibilities apply across all roles in this band, with scope, autonomy, and accountability increasing with seniority as described.
Operations & Governance
- Support and/or own (depending on level) clinical technology business processes end-to-end, including build, materials, and training.
- Align and engage stakeholders across functions and regions; contribute to or govern system decisions and ensure IT-compliant deployment.
- Monitor compliance and contribute to continuous review of operational efficiency across platforms within the function's remit.
- Partner with QA and IT to support or ensure compliant technology deployment across clinical systems.
- Translate business needs into IT requirements and solutions, identifying and removing operational inefficiencies across clinical systems and workflows.
Clinical Reporting (Business Ownership)
- Define and maintain standard clinical reporting requirements and consistent, regionalised KPI metrics for Clinical Operations.
- Act as a business stakeholder for the centralised IT reporting team, specifying requirements for dashboards, data model inputs, and report outputs.
- Validate, interpret, and govern the use of clinical reporting outputs (e.g., Power BI dashboards) to ensure they meet operational and compliance needs.
- Drive data-informed decision-making across Clinical Operations by ensuring relevant teams understand and act on standardised clinical reporting.
- Identify gaps in current reporting capability and define interim solutions in collaboration with IT.
Veeva (Business Ownership)
- Support, contribute to, or own (depending on level) the clinical roadmap and strategy for Veeva, working cross-functionally with Biometrics, PM, Medical, and GSC, and partnering with IT on technical configuration and integration.
- Define clinical requirements and priorities for system integration, vendor relationships, and release governance for Veeva, with IT leading technical delivery.
- Drive adoption and support user compliance across regional clinical teams, including audit trail design and data quality governance activities from a clinical business perspective.
Operational Scaling & Integration
- Support the function in enabling regional and global clinical teams to scale effectively for complex, multi-regional studies.
- Contribute to integration of processes, systems, data, and reporting across the organisation to strengthen operational maturity and performance.
Stakeholder Engagement & Collaboration
- Collaborate with IT to ensure system integrations, data flows, and compliance frameworks support clinical operations and organisational reporting needs.
Engage stakeholders to ensure technology, AI, and reporting initiatives align with business strategy and operational requirements, with seniority of stakeholders engaged increasing with level.
- Facilitate communication and alignment across teams to support successful change adoption and continuous improvement.
Senior Manager / Manager
Contribute to the clinical roadmap, prioritisation, and adoption activities for one or more pillars above (AI & Automation, Clinical Reporting, Veeva, Obvio), partnering with IT on technical delivery.
- Lead cross-functional project management of clinical systems and technology initiatives, coordinating requirements, timelines, stakeholder alignment, and delivery across functions including QA, IT, Biometrics, PM, Medical, GSC, BD/OSL, and IT, from initiation through to adoption.
- Drive resolution of operational issues and project tasks through to completion, escalating as appropriate.
- Lead end-to-end project planning for clinical systems and technology initiatives, including defining scope, objectives, milestones, and success criteria in collaboration with functional stakeholders and IT, and maintaining project plans, charters, and schedules throughout delivery.
- Drive project execution by coordinating workstreams, tracking progress against plan, managing interdependencies, and ensuring timely delivery of outputs and decisions across functions; proactively identify and address blockers to keep initiatives on track.
- Coordinate resource requirements across clinical systems and technology initiatives, including identifying internal capacity constraints and input needs from cross- functional teams (QA, IT, Biometrics, PM, Medical, BD/OSL), and work with the Director to address resource gaps to support delivery.
- Identify, assess, and manage project risks and issues across clinical systems and technology initiatives, maintaining risk registers, implementing mitigations, and escalating to the Director where risks could impact delivery timelines, quality, or compliance.
- Lead change management activities for clinical systems and technology initiatives, including stakeholder impact assessment, communication planning, training coordination, and adoption tracking, to support sustained behavioural change and consistent use of clinical systems and platforms.
- Manage scope across clinical systems and technology initiatives, ensuring requirements are clearly defined and agreed with stakeholders at project outset, and that scope changes are formally assessed, documented, and approved before being incorporated, to protect delivery timelines and outcomes.
- Where applicable, provide day-to-day line management, coaching, and development for Lead, Specialist and/or Senior Specialist team members, including setting objectives and managing performance.
Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to talking to you about working at Novotech.
Responsibilities:
Core responsibilities apply across all roles in this band, with scope, autonomy, and accountability increasing with seniority as described.
Operations & Governance
- Support and/or own (depending on level) clinical technology business processes end-to-end, including build, materials, and training.
- Align and engage stakeholders across functions and regions; contribute to or govern system decisions and ensure IT-compliant deployment.
- Monitor compliance and contribute to continuous review of operational efficiency across platforms within the function's remit.
- Partner with QA and IT to support or ensure compliant technology deployment across clinical systems.
- Translate business needs into IT requirements and solutions, identifying and removing operational inefficiencies across clinical systems and workflows.
Clinical Reporting (Business Ownership)
- Define and maintain standard clinical reporting requirements and consistent, regionalised KPI metrics for Clinical Operations.
- Act as a business stakeholder for the centralised IT reporting team, specifying requirements for dashboards, data model inputs, and report outputs.
- Validate, interpret, and govern the use of clinical reporting outputs (e.g., Power BI dashboards) to ensure they meet operational and compliance needs.
- Drive data-informed decision-making across Clinical Operations by ensuring relevant teams understand and act on standardised clinical reporting.
- Identify gaps in current reporting capability and define interim solutions in collaboration with IT.
Veeva (Business Ownership)
- Support, contribute to, or own (depending on level) the clinical roadmap and strategy for Veeva, working cross-functionally with Biometrics, PM, Medical, and GSC, and partnering with IT on technical configuration and integration.
- Define clinical requirements and priorities for system integration, vendor relationships, and release governance for Veeva, with IT leading technical delivery.
- Drive adoption and support user compliance across regional clinical teams, including audit trail design and data quality governance activities from a clinical business perspective.
Operational Scaling & Integration
- Support the function in enabling regional and global clinical teams to scale effectively for complex, multi-regional studies.
- Contribute to integration of processes, systems, data, and reporting across the organisation to strengthen operational maturity and performance.
Stakeholder Engagement & Collaboration
- Collaborate with IT to ensure system integrations, data flows, and compliance frameworks support clinical operations and organisational reporting needs.
Engage stakeholders to ensure technology, AI, and reporting initiatives align with business strategy and operational requirements, with seniority of stakeholders engaged increasing with level.
- Facilitate communication and alignment across teams to support successful change adoption and continuous improvement.
Senior Manager / Manager
Contribute to the clinical roadmap, prioritisation, and adoption activities for one or more pillars above (AI & Automation, Clinical Reporting, Veeva, Obvio), partnering with IT on technical delivery.
- Lead cross-functional project management of clinical systems and technology initiatives, coordinating requirements, timelines, stakeholder alignment, and delivery across functions including QA, IT, Biometrics, PM, Medical, GSC, BD/OSL, and IT, from initiation through to adoption.
- Drive resolution of operational issues and project tasks through to completion, escalating as appropriate.
- Lead end-to-end project planning for clinical systems and technology initiatives, including defining scope, objectives, milestones, and success criteria in collaboration with functional stakeholders and IT, and maintaining project plans, charters, and schedules throughout delivery.
- Drive project execution by coordinating workstreams, tracking progress against plan, managing interdependencies, and ensuring timely delivery of outputs and decisions across functions; proactively identify and address blockers to keep initiatives on track.
- Coordinate resource requirements across clinical systems and technology initiatives, including identifying internal capacity constraints and input needs from cross- functional teams (QA, IT, Biometrics, PM, Medical, BD/OSL), and work with the Director to address resource gaps to support delivery.
- Identify, assess, and manage project risks and issues across clinical systems and technology initiatives, maintaining risk registers, implementing mitigations, and escalating to the Director where risks could impact delivery timelines, quality, or compliance.
- Lead change management activities for clinical systems and technology initiatives, including stakeholder impact assessment, communication planning, training coordination, and adoption tracking, to support sustained behavioural change and consistent use of clinical systems and platforms.
- Manage scope across clinical systems and technology initiatives, ensuring requirements are clearly defined and agreed with stakeholders at project outset, and that scope changes are formally assessed, documented, and approved before being incorporated, to protect delivery timelines and outcomes.
- Where applicable, provide day-to-day line management, coaching, and development for Lead, Specialist and/or Senior Specialist team members, including setting objectives and managing performance.
Minimum Qualifications & Experience:
Tertiary qualifications in life sciences or a related field.
Manager: Minimum 5+ years’ experience in clinical operations, process optimisation, clinical systems management, or related functions, with demonstrated ability to coordinate and project manage initiatives across functions.
Experience in clinical trials within a CRO, pharmaceutical, or biotech environment is essential. Candidates must have a solid understanding of clinical operations, including study lifecycle, site management, monitoring, and GCP compliance, and demonstrated experience contributing to process improvement initiatives that have strengthened clinical operational efficiency, quality, or scalability.
Demonstrated experience with, or exposure to, clinical systems such as Veeva and/or Obvio (or equivalent eClinical/CTMS platforms) from a clinical operations/business perspective. Technical configuration/development experience is not required.
Experience with clinical use cases for AI tools and automation within a clinical operations or clinical quality context is highly desirable. This role partners with IT for technical delivery and does not require AI development expertise.
Experience with clinical KPIs, reporting requirements, and operational dashboards (e.g., Power BI, Excel), and working with IT/BI teams to translate business needs into reporting solutions. Strong proficiency in Microsoft Excel is required, including the ability to work with clinical data sets, build and maintain reports, and use functions such as pivot tables, VLOOKUP/XLOOKUP, and conditional logic to support operational analysis and decision-making. Candidates must demonstrate an understanding of clinical data structures and the ability to perform meaningful reporting on clinical operational metrics.
Strong customer and stakeholder focus, with excellent communication, influencing, and interpersonal skills.
Proven ability to manage multiple priorities, exercise independent judgement, and deliver high-quality outcomes under time pressure, including in ambiguous or newly-defined operating environments.
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