Are you a Clinical Operations Consultant looking for a new challenge in a rapidly growing clinical research organisation focused on medical imaging, with a strong focus on technology and digital health? A proven background in clinical trials is essential.

The Clinical Operations Director is a new operational management role appointed with the responsibility of enhancing service levels and scaling clinical services. Encompassing responsibility for Image and Data QC, Processing and Analysis, and Site Qualification and Management and reporting to the VP Programme Management, the role holder will be accountable for ensuring that all services within their area of responsibility deliver to customer and business Key Performance Indicator requirements, meet revenue and margin budgets and targets, and are in full compliance with company and industry quality and regulatory frameworks. Developing a strong culture of accountability, seamless service delivery, continuous improvement and driving efficiency gains are key success criteria for this role.

Responsibilities

Leadership of the Clinical Operations management team, encompassing Image Processing and Analysis Manager and Senior Lead for Site Management, and respective team/function leads to:

Deliver efficient Clinical Operations services

• Set ongoing priorities for Clinical Operations functions to meet all project delivery milestones, revenue, income, and cost targets
• Oversee and monitor daily Clinical Operations activities to ensure their timely delivery, with regular reporting of performance; establishing KPIs and dashboards to responsively manage each functional area
• Ensure service levels meet customer requirements and are delivered in full compliance with quality management system and regulatory standards
• Measure, report, reduce and solve any quality issues, deviations, and re-work/inefficiencies to ensure all services are delivered "right first time, every time"
• Resource planning and recruitment to deliver on all company budget targets, maintaining a climate to attract, retain and motivate top quality personnel
• Maintain all systems and procedures necessary for the effective operational delivery of the areas of responsibility; and simplify and streamline cross-functional tasks wherever required
• Define and implement with HR an effective staff training plan, including supervision, and mentoring of managers and team leaders

Scaling of operational capabilities and capacity

• Fully assess and optimise workflows and processes in each functional area through implementation of process change initiatives such as Lean, Six Sigma, Kaizen.
• Define and lead a culture of continuous improvements through such initiatives, setting objectives including stretch goals for efficiency and service level improvements
• Motivate staff to meet or surpass contractual and/or internal delivery targets and KPIs
• Define operational requirements in response to expansion and extension of services, reviewing current capacity and efficiencies, making recommendations, and building business case for systems and resources as required
• Develop the operational capabilities in response to new business opportunities defined in company strategy, to deliver new product and service lines

Qualifications and skills:

Essential

• 7 years + experience within a senior clinical operations role within the clinical trial domain, preferably including neurological diseases and neuroimaging
• 5 years + demonstrated experience of line management and team leadership
• Track record of developing/growing operational capabilities and processes and implementing improvements through Lean, Six Sigma and Kaizen type performance and change processes
• Strong financial understanding, including experience of setting and managing departmental budgets and forecasts
• Thorough working knowledge of Good Clinical Practices, including ICH Guidelines, FDA's Code of Federal Regulations, Clinical Research Ethics, GDPR/HIPAA, and other regional and local requirements and regulations
• Educated to at least degree level in a relevant health science or business discipline