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CDC Trial Manager

Category:  Clinical Development and Medical
Location: 

Sydney, New South Wales, AU

   

Do you want to be part of a company that changes patient’s lives? An exciting opportunity has arisen for an experienced trial manager within our growing Clinical Operations Team. You will be working a full trial management cycle role, from site selection to closeout, working closely with internal and external partners to ensure  trial milestones and deliverables are met.

 

About the department

Novo Nordisk is a global company with a fast-growing number of employees in Oceania and approximately 44,000 around the world. 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.

 

The position

The role would be ideal for an individual keen to demonstrate and drive their trial management skills whilst gaining experience working with industry-leading systems and processes. The successful candidate will play a key role in managing multiple trials, driving site start-up, patient recruitment, risk management, monitoring reports review and co-monitoring activities in accordance with ICHGCP guidelines.

 

Key responsibilities include (but not limited to):

  • Managing clinical trials from start up to database lock and close out;
  • Prepare, organise, conduct and follow-up on routine monitoring, co-monitoring and close out visits as per relevant trial plan;
  • Motivate and train CRAs and also investigators and site staff on all aspects of the trial to ensure obligations with regards to study timelines and deliverables;
  • Site engagement and customer relationships;
  • Ethics submissions are made in a timely manner;
  • Manage trial finances in a timely manner;
  • Adherence to ICH-GCP and any other regulatory guidelines and requirements including adverse events and serious adverse event reporting;
  • Compliance with mandatory SOPs as agreed for the study;
  • Complete all reports accurately and within the predetermined timelines;
  • Team mentoring and trial quality checks;
  • Frequent local and interstate travel.

 

Qualifications & Requirements

  • Tertiary qualifications in a related science or health care discipline.
  • Proven success in managing clinical trials from start to finish and in accordance with ICH-GCP methodology.
  • Excellent working knowledge of ICH-GCP, ethical and regulatory requirements.
  • Excellent leadership skills, interpersonal skills, presentation skills and the ability to work well and autonomously, in small teams and with a wide range of varying stakeholders.
  • Excellent organisational skills - ability to organise, take initiative and follow-up independently.
  • Familiarity with computer systems particularly MS and electronic data capture and CTM systems.
  • Focus on detail and quality work.
  • Ability and willingness to travel.
  • You must either be an Australian Citizen or have a current residency Visa to live and work in Australia.

 

Benefits

This is a permanent and comes with an attractive salary package as well as the ability to work predominantly from home or remotely, with attendance in the office as required.

 

Contact

For further questions, you may reach out to BMYS@novonordisk.com.

 

Application Deadline

Applications will be processed as they come in so please apply today for this life-changing opportunity!

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

 

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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