Cdc Feasibility Manager

1 week ago

Sydney, New South Wales, Australia Novo Nordisk Full time

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 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 datadriven 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.

Qualifications

  • Must have a minimum of 35 yearsexperience 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

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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