Job Description

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Senior Clinical Research Associate

Category: Clinical Development and Medical

Location:

Manchester, North West, GB

The position
Novo Nordisk has a very bright future ahead with many new innovative products in the pipeline. To reach our ambition of improving the lives of millions of people, we are now recruiting a Senior Clinical Research Associate (CRA) for our Clinical Research Team.

Please note, this is a UK field-based role within the North West Region, not eligible for relocation, reporting directly to the Clinical Research Manager in our UK affiliate.

As a Senior CRA, you will be the primary point of contact between site staff and Novo Nordisk and act as an ambassador for the company. You will be responsible for managing clinical trial sites at every stage of the clinical trial process in accordance with the company\'s policies and procedures, relevant legislation, and ICH GCP requirements, whilst maintaining the standards of the Novo Nordisk Way.

Your main responsibilities will include:

• Overall site management, including site monitoring and remote monitoring as applicable in accordance with the Monitoring Plan and Risk Indicator Reports
• Ensure that trial site staff are properly trained to conduct the trials, provide necessary training, and identify and flag any development areas and implement mitigations
• Managing trial sites to meet patient recruitment and retention target, aimed at successful completion of the clinical programme
• Production of documents for submission of new studies and collection of documentation required for clinical trial reports

You will demonstrate good communication skills with both internal and external stakeholders (investigators and site coordinators) for the successful implementation of your main deliverables.

Qualifications
You should have an educational background preferably within the Health Sciences (biology, pharmacy etc). Additional post graduate training and degrees will be considered as an asset.

The ideal candidate should have:

• Solid work experience in the same or similar positions in the pharmaceutical industry (including CROs) and Healthcare/NHS
• Solid knowledge of clinical trial methodology
• Solid knowledge of the clinical trials environment - ICH GCP, regulatory issues, sops
• Good working knowledge of electronic clinical trials systems - CTMS, EDC, RTSM, electronic TMF
• Mentoring experience, leading other more junior CRAs to improve career path, providing guidance, motivation, emotional support, and role modelling.

Preferably, you can work independently and have a good understanding of project management, as well as the ability and willingness to adjust quickly to new situations in a continuously developing environment with a service minded attitude.

About The Department
The UK Clinical Research team of approximately 100 employees is part of the UK Clinical, Medical and Regulatory (CMR) Department with responsibility for running all global development clinical trials in the UK. The team has trial management and administration functions based in the UK Gatwick office and 4 field-based CRA teams to cover the monitoring of clinical trial sites across the country.

You will be part of a highly motivated Clinical Operations team responsible for the planning, execution and completion of projects related to the development of new medicinal products in the areas of diabetes, obesity, haemophilia, NASH, Alzheimer, cardiology, and growth hormone.

The scope of our activities is from phase I to IV clinical trials and non-interventional studies in collaboration with our Headquarters and local stakeholders. Our environment is characterised by a global network with challenging assignments in a project centric organisation. We focus on continuous personal and professional development and exciting opportunities which arise within or international organization.

Application support

We are an equal opportunities employer, and we commit to an inclusive recruitment process and equality of opportunity for all our job applicants. If you\'re a person with a disability, if you\'re neurodivergent, and need any adjustments to be made during the application and selection process, please send an email to GIFJ@novonordisk.com. Please include your name, the role you are interested in and the type of adjustment your need.

Working at Novo Nordisk
Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That\'s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it\'s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 50,000 employees. Together, we go further. Together, we\'re life changing.

Contact
Please submit your application via the Novo Nordisk website. We are unable to accept direct CVs.

Deadline
1st of August 2023

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.

Novo Nordisk