Job Description

Are you ready to make the next step in your professional development in a global expanding company? Are you interested in improving the lives of millions of people, working in a company that works with innovation and is a leader in diabetes? Join us and become a Startup Clinical Trial Assistant (CTA) for Novo Nordisk South Africa (Johannesburg)!

The position

As a Startup Clinical Trial Assistant you will be supporting startup team with initial Clinical Trial Application (CTA) to Health Authority (HA) & EC. The base location for this position will be in Johannesburg and will report directly to the Clinical Research Manager in South Africa.

Your Key responsibilities includes the the following:

• Support startup team with the initial Clinical Trial Applications (CTAs), Amendments & other ad hoc applications (e.g.: annual EC renewals, additional PI, site staff, 6 monthly progress reports, notifications, etc) to HA & EC. Upload all submission & other submitted documents to CTMS. Print, prepare and compile all documents for submissions. Initiate, update and maintain submission trackers for all trials.
• Upload and maintain contracts, CDA/Investigator Agreements to relevant systems as needed. Courier of study materials as needed. Invoice processing for all trials submitted including ad hoc invoices. Archiving of trial documents to relevant vendors and HQ. Startup meeting planning and other ad hoc meetings.
• Oversight of all trial documentation for assigned clinical trials. Support in preparation and submission of CTA package. Timely collection, filing and preparation for long term archival of site and country level trial documents in TMF according to Novo Nordisk SOPs.
• Assist in/perform QC of trial documents. General CTA duties when needed. Assist with customisation of submission letters and other relevant documents. Assist with translations of clinical trial documents, if needed. Assist with relevant systems setup and maintenance.
• Administrative duties such as travel arrangements, minute taking, meeting setup, etc for clinical trial activities. Liaise with insurance vendors for insurance policies for clinical trials.

Qualifications and experience

The ideal candidate will have the following qualifications:

• University degree in Life Sciences from a recognised tertiary institution
• At least 1-2 years as a Clinical Trial Assistant with experience in a startup setting.
• Excellent MS (Excel, Word, PowerPoint) are a must.
• Strong communication skills are essential.

Other important skills to be successful in this position are:

• Ability to influence and collaborate with internal and external stakeholders.
• Great communication skills (verbal and written).
• Good planning, time management and organizational skills.
• Demonstrating cross-functional collaboration and teamwork.
• Good decision-making and problem-solving ability.
• Demonstrating agility in the ways of working, be self-motivated, be patient-centric and have a quality mindset as well as being result-oriented.
• Proficiency in the English language (Oral & Written)
• Able to work efficiently and independently.
• Attention to detail and follow through and strong time management.

About the department

Clinical Development Centre South Africa (CDC South Africa) is a dynamic unit in the Clinical Research organisation. The CDC South Africa is responsible for planning, execution and finalisation of clinical trial activities e.g. project management and administrative tasks related to the conduct of clinical trials. In CDC South Africa we have a team of highly skilled and passionate CRAs, Clinical Project Managers and Clinical Trial Administrators. We value an open, trust-based and creative working environment as well as a great team spirit. Our working environment is characterised by interesting and demanding assignments and continuous professional development opportunities.

Working at Novo Nordisk

We are a proud life-science company, and life is our reason to exist. Were inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at Novo Nordisk, life means many things - from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why were all here - to ensure that people can lead a life independent of chronic disease..

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We are happy to discuss flexible working, depending on the role and subject to business needs.

Contact

Please submit your application via the Novo Nordisk website as we are unable to accept direct CVs. Additionally, please make sure to add a brief cover letter telling us why youd be interested to join us as Novo Nordisk and why you are our ideal candidate.

Deadline

25.01.2024

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, were life changing.

Novo Nordisk