Study Start Up Specialist

Novo Nordisk; Crawley Down; On-site; GBP 45,000 - 65,000; Full time

Job summary

Novo Nordisk in the United Kingdom seeks a Start Up Specialist to deliver regulatory, ethics and national approvals for clinical trials. You will work with the CDC UK team to negotiate site contracts, secure approvals, and activate sites in line with UK regulations and ICH GCP.

Key responsibilities include submission leadership via IRAS, preparing Clinical Trial Agreements (mCTA), and coordinating amendments with Trial Managers while ensuring timely delivery and compliance with Novo Nordisk SOPs.

Qualifications

• Experience in pharma/healthcare admin; degree desirable.
• 2
• 3

Responsibilities

• Prepare and submit UK approvals (HRA, MHRA, REC) using IRAS.
• Handle regulatory lifecycle and local approvals.
• Support mCTA negotiations and contract execution.
• Coordinate amendments and provide submission docs on time.
• Provide trial status updates and assessment to the Trial Squad.
• Ensure compliance with UK law, ICH GCP and Novo Nordisk SOPs.
• Contribute to process improvements in approvals.

Skills

Administrative experience

Clinical trial knowledge

GCP training

Presentation skills

Communication skills

Influencing skills

Adaptability

Teamwork

Results delivery

Planning & organizing

Attention to detail

Customer service

Change management

Education

Degree in pharma/healthcare or equivalent

Tools

IRAS

CPMS

Coupa

novoTime

Microsoft Office

Job description

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.

Your new role

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.

Your day-to-day responsibilities will include:

• 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

Your new department

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.

Your skills & qualifications

We are looking for a highly organised, detail-oriented professional who enjoys working across a variety of stakeholders in a fast-changing regulatory environment. To succeed in this role, you will bring with you:

• 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 novoTime, 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

Working at Novo Nordisk

Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with determination, constant curiosity and a commitment to finding better ways forward. For over 100 years, this dedication has driven us to build a company focused on lasting change for long-term health. One where diverse thinking, shared purpose and mutual respect come together to create extraordinary results. When you join us, you're not just starting a job – you're becoming part of a story that spans generations.

What we offer

There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind.

Deadline

13 September 2026. (Applications are reviewed on an ongoing basis).

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.