Study Start Up Specialist

Start Up Specialist United Kingdom

Help bring new clinical trials to life in the UK – and play a vital role in getting life-changing treatments to the patients who need them. If you thrive on detail, regulation and making things happen, this is your moment.

As our new Start Up Specialist, you will be responsible for delivering regulatory, ethics and national approvals for clinical trials managed by our Clinical Development Centre UK (CDC UK). Working in close partnership with the Start Up Trial Manager and the wider Trial Squad, you will negotiate and maintain site contracts, secure site approvals, and ensure timely site activation – all in line with UK regulations, ICH GCP and Novo Nordisk's quality standards.

• Preparing and submitting UK nation (HRA and devolved nation), MHRA and Research Ethics Committee (REC) approvals across the trial lifecycle, acting as submission lead via systems such as IRAS, and booking REC meetings as required
• Handling regulatory lifecycle requirements of clinical trial authorisations and securing local secondary care, primary care and Patient Identification Centre (PIC) approvals
• Supporting preparation of the Clinical Trial Agreement (mCTA), leading cost negotiations with R&D offices at Trusts/Boards and GP sites, and arranging full execution of contracts
• Coordinating amendments for ongoing trials with the CDC Trial Manager and providing 'Green-light' and submission documentation to Trial Managers and Clinical Trial Assistants within agreed timelines
• Providing trial status updates and FPFV likelihood assessments to the Trial Squad, and reviewing and approving clinical trial labels in line with UK regulatory requirements
• Ensuring compliance with UK legislation, the national governance framework, EU directives where applicable, ICH GCP and Novo Nordisk SOPs – including sTMF oversight, filing and archiving
• Contributing to ongoing process improvement by interpreting and standardising new approvals processes and communicating changes to relevant stakeholders

Within Clinical Development Centre UK (CDC UK), the team responsible for delivering high-quality clinical trials across the UK. We work in close-knit Trial Squads where Start Up Specialists, Trial Managers and Clinical Trial Assistants collaborate to bring new studies to life – navigating an evolving approvals landscape and ensuring patients in the UK can access tomorrow's treatments today.

• Some experience working in an administrative role within the pharmaceutical or healthcare environment; a degree or equivalent qualification is desirable
• Good knowledge of clinical trial methodology and an up-to-date understanding of the UK clinical trials environment – including ICH GCP, regulatory and ethics requirements and SOPs – with a valid GCP training certificate
• Hands‑on experience using internal and external IT systems such as IRAS, CPMS, Coupa and novo
  
  Time, alongside strong computer literacy and proficiency in Microsoft Office (Word, Excel, PowerPoint)
• Strong presentation, communication and influencing skills, with the ability to liaise effectively with R&D offices at Trusts/Boards, GP sites and internal Trial Squad members
• Flexibility and resilience to manage a wide range of minor and major tasks from different stakeholders, with the ability to interpret, standardise and communicate evolving approvals processes
• Demonstrated competencies in working together, delivering results, planning and organising, concern for quality and detail, external customer service and embracing change

Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with…