Clinical Trials Approvals Officer

3 weeks ago


London Gatwick Airport, United Kingdom Novo Nordisk Full time

Would you like to be part of our mission to be a world-leading Clinical Development Centre (CDC) focused on asking difficult questions but delivering high impact science?

Are you an expert in project planning, management, and execution from site selection to post-clinical trial activities? Do you thrive in a collaborative, fast-paced and dynamic working environment?

If you are a qualified professional with a true passion for Clinical Research, we want to hear from you

**The Position**

We currently have a vacancy for a Clinical Trial Approvals Officer (CTAO) in the Start-up and Operations team.

The purpose of the role is to obtain and maintain the ethics and health research authority approvals for all clinical trials conducted within the UK by the UK Clinical Research team and to negotiate contracts with the research and development organisations at clinical trial sites, keeping costs close to those outlined in the Master Clinical Trial Agreement. All tasks must be performed in accordance with external regulations and working practises, the Company’s policies and procedures and ICH GCP requirements.

You will work closely with colleagues in the Start-up and Operations team and with the local trial manager to set timelines and agree the target costs. You will be first point of contact for Medicines and Healthcare products Regulatory Agency (MHRA), health research authorities, ethics committees and research and development organisations.

**Qualifications**
- You will have good interpersonal and negotiation skills
- You know how to interpret and standardise new processes and communicate to other stakeholders is essential due to the evolving approvals environment and the constant changes to the approval process.
- You have got confidence on the phone and excellent IT skills
- You’re a fluent English speaker

**About the Department**

You will be part of a highly motivated UK CDC team responsible for the planning, execution and completion of projects related to the development of new medicinal products.

The UK CDC is a team of 70+ highly skilled and ambitious colleagues responsible for the planning and execution of clinical trial activities in accordance with the Product Development Plans of Novo Nordisk. We focus on continuous personal and professional development and exciting opportunities which arise within our international organization.

**Working at Novo Nordisk**

At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we

seize them. From research and development, through to manufacturing, marketing and sales - we’re all working to move the needle on patient care.

**Contact**

**Deadline**

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

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.



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