CDC Feasibility Manager

Are you a high performing individual who would want to take part in changing patient’s lives worldwide? Novo Nordisk is looking for Feasibility Manager who has strong knowledge of clinical trial regulations across Australia and New Zealand (AU/NZ). If this is you, we invite you to join our team and apply today!

About the Department

Novo Nordisk has a strong reputation and relationships with trial sites in Australia, supported by a global philosophy and tradition centred on research and clinical trials in all our therapy areas.

Novo Nordisk (NN) Oceania is a high performing affiliate within a mature pharma market environment. You will have the opportunity to liaise with colleagues from CMRQ (Clinical, Medical, Regulatory and Quality), as well as Medical Affairs department. You will also have an opportunity to work with healthcare professional (HCPs) in clinical sites, and all vendors involved in the clinical trial process.

The Position

The successful candidate will supervise the feasibility and site selection process for all trials in the CDC (Centers for Disease Control and Prevention), according to agreed timelines. Ensure that selected clinical trial sites have the adequate resources, qualification and setup to perform the study and are compliant to national and global guidelines (NHMRC national statement, ICH-GCP), as well as Novo Nordisk Quality processes. Create and maintain relationship with key opinion leaders and preferred clinical trial sites in current and new therapeutic areas, developing a network of stakeholders to optimize and accelerate the development of Novo Nordisk clinical pipeline in Australia and New Zealand.

The role will directly report to the Clinical Research Manager (CRM).

Other accountabilities are below, but is not limited to:

• Be responsible for country and site feasibility, Involved from TPR (Total Peripheral Resistance) to Country allocation/site selection and in case additional sites are required, conduct data-driven country and site feasibility for studies, including inputs to protocol design (if relevant), and identify potential site list from SALINA based on historical experience and inputs from clinical operations team.
• Ensure site specific confidentiality disclosure agreements (CDA) are executed prior to sharing feasibility questionnaire, collaborate with the local clinical operations teams, regulatory, medical, market and pricing teams for conducting feasibility and site selections, provide country feasibility inputs into Trial Portfolio Review, use all competitive intelligence data to assess and propose recruitment rates and number of sites, and collate lessons learned from all trials and use it while assessing feasibility of future trials.
• Provides data-driven study startup forecasts, benchmarking assumptions, and provide inputs to enrollment plans, may participate in the evaluation of new informatics and digital technologies, such as clinical trial registry search tools, enrolment modelling and simulation tools and protocol feasibility assessment tools, constantly maintain and generate relations with trial Sites, and maintains and refines the internal HCP/Site information in collaboration with Study Startup, Clinical Operations and Medical.
• Build and maintain a sound knowledge of historical performance, patient treatment pathways, competitor trials, Patient networks, advisory groups and country clinical research environment for new and established therapy areas, deliver final confirmation on country allocation to Global Trial Planning (GTP) Team, build and maintain relationships with internal and external stakeholders to develop clear communication methods to support study strategies, and influence and monitor local clinical environment in order to achieve business goals.
• Inform internal stakeholders about all trial / project related issues and the local therapeutic business scenario covering any current and/or potential changes in local trial related regulation and local competitor information, assist with GTP planning and portfolio management, maintains study start up tracker/tools/applications in a timely manner for optimal collaborations, develop and maintain digital clinical trial applications expertise used in NN trials to support and develop external clinical site staff, and assist the study start-up/strategic operations team with trial/study start up if required.

Qualifications

• The successful candidate must have a degree in life sciences or in related fields.
• Must have a minimum of 3-5 years-experience in clinical operations roles. Clinical trial site role experience highly beneficial.
• Excellent knowledge of clinical trial methodology
• Up to date knowledge of the clinical trials environment - ICH GCP, regulatory issues, SOP’s
• GCP (Good Clinical Practice) training attended and certificate

Working at Novo Nordisk

We are a proud life-science company, and life is our reason to exist. We’re 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 we’re all here - to ensure that people can lead a life independent of chronic disease.

Contact

Please send your CV online (click on Apply and follow the instructions).

Deadline

We will review your applications as you apply!

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.