Clinical Systems Manager

Novotech; Durham (NC); On-site; USD 110,000 - 170,000; Full time

Job summary

Novotech is seeking a senior leader to drive the Clinical Systems & Technology function. You will own the end-to-end lifecycle of clinical technology initiatives, lead AI use case identification, and govern centralized reporting including Power BI dashboards.

Collaboration across QA, IT, Biometrics, PM, Medical, and BD/OSL is essential to translate operational needs into IT-compliant solutions and scalable processes.

Qualifications

• Tertiary qualification in life sciences or IT-related field.
• 5+ years in clinical operations, process optimisation or clinical systems management.
• Experience translating needs into KPI reports and dashboards (Power BI, Excel).
• Familiarity with Veeva and Obvio or similar eClinical/CTMS platforms.
• Strong cross-functional coordination across QA, IT, Biometrics, PM, Medical and BD.

Responsibilities

• Own or co-own clinical technology processes end-to-end, including build, materials, and training.
• Govern system decisions and ensure IT-compliant deployment across regions.
• Define and maintain standard reporting requirements and KPI metrics for Clinical Operations.
• Lead adoption, training, and change management for AI tools and automation.
• Project-manage clinical systems initiatives from requirements through adoption.
• Scale operations to multi-regional studies and ensure data-integrated reporting.

Skills

Project management

Stakeholder engagement

Data analysis

Power BI

Excel advanced

Cross-functional collaboration

Clinical operations

Education

Tertiary qualifications in life sciences or information technology

Tools

Veeva

Obvio

Power BI

Excel

Job description

The Clinical Systems & Technology function provides operational leadership for the clinical business ownership of clinical technology, automation, and clinical reporting across the organisation. 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.

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.

This position also 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.

Responsibilities:

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.

AI Tools & Automation (Clinical Use Cases)

• Lead the identification, prioritisation, and definition of clinical AI use cases in partnership with IT, translating clinical operational needs into clear requirements and ensuring solutions are fit for purpose.
• Govern the clinical AI and automation roadmap, ensuring initiatives remain aligned to clinical operational priorities and that the pipeline of use cases is regularly reviewed and updated as the capability matures.
• Drive clinical adoption, training, and change management for AI tools and automation

Clinical Reporting (Critical)

• 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.

Business Ownership

• Support, contribute to, or own (depending on level) the clinical roadmap and strategy for eConsent, ePro, and eCoa, working cross-functionally with Biometrics, PM, and BD/OSL, and partnering with IT on technical configuration and integration.
• Define clinical requirements and priorities for platform integration, vendor relationships, and release governance, including clinical process design inputs.
• Drive adoption and support user compliance across regional clinical teams.

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.
• Contribute to the clinical roadmap, prioritisation, and adoption activities for one or more pillars above 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.

Minimum Qualifications & Experience:

• Tertiary qualifications in life sciences, information technology, or a related field.
• 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 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.
• 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.
• Strong customer and stakeholder focus, with excellent communication, influencing, and interpersonal skills.

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 contacting you regarding your application.