Senior CDC Trial Manager

Would you like to join a team that plays a crucial role in the ambitious drug development programs at Novo Nordisk? Are you a devoted clinical professional who enjoys working in a dynamic and multicultural work environment? Then you could be our new Senior Clinical Development Center (CDC) Trial Manager. Apply now and join us for a life-changing career!
 

About the department
Novo Nordisk (NN) is a global healthcare company with 100 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat obesity, haemophilia, growth disorders, rare diseases, and other serious chronic diseases. Headquartered in Denmark, Novo Nordisk employs over 55,000 people globally and markets its products in more than 170 countries.

As part of a globally successful pharmaceutical business, Novo Nordisk Oceania (Australia and New Zealand) is a high-growth affiliate with an exciting growth trajectory and pipeline in new products and therapy areas in the coming years. We proudly live our purpose of improving the lives of patients within the therapy areas our products treat and put both patients and people firmly in the centre of everything we do.

The person in this position will report to the Clinical Operations Manager.

The position
This role will be in charge of day-to-day planning, executing, and reporting (from site feasibility up to and including study site close-out) of assigned clinical trials in Oceania CDC.
The Senior CDC Trial Manager is the single point of contact and lead in making sure that deliverables are met as per project timelines, within budget and complying with Protocol, country regulatory requirements, Helsinki Declaration, Good Clinical Practice (GCP) and Novo Nordisk Standard Operating Procedures (SOPs). Furthermore, this position will assist in the mentoring and supervision of less experienced colleagues, best practice sharing, active participation in CDC meetings and workshops, and contributes to the preparation of local guidelines/processes.

The key responsibilities include (but are not limited to): 

• Overall trial organization and coordination within the country including assessing site selection, planning resources and budget, risk analysis and developing a strategy for trial implementation. 
• Ensure compliance with the application, timely and accurate communication of trial issues and function as key point of contact for Clinical Research Associates (CRAs), Global Trial Managers (GTMs), Clinical Operations Manager (COM), Clinical Research Manager (CRM) and CDC Head. 
• Ensure effective communication of all trial/project-related issues between HQ, CDC, the region, and other internal/external stakeholders, and collaborate with COM and CDC Feasibility Manager (FM) to ensure efficient and accurate site feasibility visits including analysis of site logistics, site personnel performance/quality indicators and accountability for patient recruitment strategies.
• Work in collaboration with Study Start-Up (SSU) to organize for prompt Human Research Ethics Committee (HREC), Research Governance Office (RGO) and Therapeutic Goods Administration (TGA) approval by making timely submissions and providing responses, as requested.
• In charge of representing CDC countries in relevant study meetings and organizing these meetings: Trial Squad Meetings Monitor meetings, Investigator meetings, and Study Result meetings, as well as assist in CDC TMs and be actively involved in new CDC Project Managers (PMs) onboarding and mentoring.

Qualifications

• Minimum of bachelor’s degree level in Life Science, Pharmacy or Nursing qualification or equivalent is required. 
• Minimum of 5 years working experience as a Trial Manager (equivalent Project manager role) with tried proficiency and previous experience of successful trial management and monitoring in clinical trials in accordance with ICH GCP.
• With trial and resource management skills, understanding of clinical trial regulations/methodology across Australia/New Zealand, as well as up-to-date knowledge of the clinical trials environment (ICH GCP, regulatory issues, SOP’s) and drug development process.
• Computer literacy and IT skills utilizing SAP, Clinical Trial Management System (CTMS), Electronic Data Capture (EDC) and electronic Trial Master File (eTMF).
• Must either be an Australian or New Zealand Citizen or have a current residency Visa to live and work in AU/NZ.

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 cover 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
Upload your CV to our online career page (click on Apply and follow the instructions). 

Deadline
Until the completion of recruitment. Applications will be screened on an ongoing basis, so you are encouraged to apply as soon as possible.
 

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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