SUMMARY
The Executive Director, Business Process & Excellence leads CiviaONE, Civia Health’s single operating model and the enabling function that makes every team’s delivery repeatable, measured and auditable. Its purpose is to remove human variability from how Civia works: every process is embedded, continually measured and improved, so Civia delivers quality with high efficiency. A participant visit should run the same way at every Civia site, in the UK or the US. That consistency is what lets Civia scale, train to one standard and assess performance like for like, with the site operations organisation as the first priority. This is a hands-on, highly accountable role, not an advisory one: the Executive Director sets the standard, measures compliance with it and improves it, and is accountable for Civia’s compliance with CiviaONE. This leader develops, owns and implements the business process infrastructure across Civia, moves the organisation to project-based ways of working with Quality by Design at its core, and serves all teams — specifically project management, site operations and recruitment — as internal clients. The role leads the CiviaONE team and multidisciplinary teams across the UK and US.
KEY RESPONSIBILITIES
CiviaONE Operating Model & Process Infrastructure Set the principles, methodology and vision for CiviaONE, and lead its implementation across Civia .
Develop, own and implement Civia’s business process infrastructure: the operating model (site and central), CiviaONE Playbook, the Study Delivery Framework and SOP/work instructions.
Partner with Quality Assurance, which retains document control and approval within the QMS, to bring the Study Delivery Framework under version control with one owner and one change route.
Define what is globally standard and what may vary locally between the UK and US, keeping local variation to the minimum that regulation requires, with regional roles informing global requirements.
Ensure every process has a named owner, clear version control and a regular review cycle to improve standards at every stage.
Maintain the CiviaONE Playbook as an audit-ready account of how Civia works, for use across the organisation, with sponsors in sales discussions and in audits.
Site Operations Standardisation Make the site operations organisation the first focus of CiviaONE: every site runs its core processes, from site start-up and screening to participant visits, data entry and close-down, in the same way, in the UK and the US.
Remove human variability from site work by building the standard into roles, checklists, tools and systems, so outcomes do not depend on which person, or which site does the task. Work with training to ensure appropriate competency checks and assessments are in place
Use the standard as the basis for scale: open new sites and onboard staff to one defined model, train to one standard and assess site and individual performance like for like.
Measure every standard process continually and improve it through one change route, so an improvement made at one site is rolled out to all sites.
Own compliance with CiviaONE: check adherence at every site and team and drive corrective action through to closure.
Project-Based Delivery & Quality by Design Lead Civia’s move to project-based ways of working, with clear governance, milestones and accountability.
Establish the CiviaONE PMO and capacity planning, so studies, change projects and resourcing are managed from one portfolio view.
Embed Quality by Design, in line with ICH E6(R3), so quality and risk are built into processes from the start.
Integrate the quality management system into the operating model, partnering with Quality on system-level CAPA.
Process, Systems & Data Change Lead multidisciplinary teams building Civia’s process, systems and data infrastructure.
Partner with the Clinical Systems and Data: Evidence at Scale teams and technology vendors , so that systems support processes as designed.
Build the data process…