Clinical Trial Manager

Full-time contract until 30 November 2025About Menzies:Menzies School of Health Research is one of Australia’s leading medical research institutes dedicated to improving Indigenous, global and tropical health. Menzies has a history of over 30 years of scientific discovery and public health achievement. Menzies works at the frontline, joining with partners across the Asia-Pacific as well as Indigenous communities across northern and central Australia.About the position:The Deadly Ears at Discharge clinical trial is funded by the National Health and Medical Research Council to assess whether an additional assessment and support during a hospital stay by Aboriginal staff to inform the ear health discharge planning will improve health outcomes. Aboriginal children at increased risk of severe otitis media (severe OM) will be eligible.The Clinical Trial Manager will manage the research team, undertake financial management of the clinical trial and ensure the clinical trial meets the relevant standards.The Clinical Trial Manager will be based in Darwin. At times, however, there will be a requirement to travel remotely as a team via light aircraft and/or 4WD for up to five days, three to four times a year.Aboriginal and/or Torres Strait Islander people are strongly encouraged to apply.What we expect from you:Manage a research team and ensure the clinical trial meets the standards of Good Clinical Practice (GCP) Guidelines, Australian Code for the Responsible Conduct of Research and National Statement on Ethical Conduct in Human Research.Undertake clinical trial financial managementManage administration of the independent Data Safety Monitoring Committee.Collect data and report on outcomes and adverse events, ensuring that data are recorded, stored or transmitted appropriatelyManage research staff recruitment and provide training, supervision, mentoring and support to build your strong team.Establish and maintain internal and external collaborative relationships.Our Selection Criteria:Postgraduate qualifications, or progress towards postgraduate qualifications in a relevant medical or health related field and extensive relevant experience; or extensive relevant experience and management expertise; or an equivalent combination of both.Demonstrated clinical trial or clinical research management experience, including knowledge of Ethical Conduct in Research, Good Clinical Practice, participant recruitment and consent.Proven experience in the development of standard operating procedures and site-specific procedures, and maintaining and monitoring compliance.Experience in data and safety monitoring and reporting, writing progress reports against study milestones, and reporting to and assisting Investigator meetingsExperience in the recruitment, supervision, mentoring and training of staff.Highly developed ability to communicate effectively, both orally and in writing, with a range of audiences including diverse cultures and a multidisciplinary team.Strong negotiation and conflict resolution skills, good judgement, flexibility and resourcefulness, and the ability to maintain confidentiality.Demonstrated high level experience building and maintaining strong collaborative partnerships with a diverse range of individuals and organisations.Demonstrated capacity to work independently under broad direction and as part of a multidisciplinary team, maintain good organisational and time management skills, effectively prioritise workloads and meet deadlines.Demonstrated financial management experience and knowledge of budget preparation, monitoring, and financial reporting and of procurement processes. Strong record keeping skills.Demonstrated experience and competency with a range of computer software including the Microsoft Office Suite.Willingness and ability to travel on light aircraft, on unsealed roads by 4WD to rural and remote communities as part of a team for up to five days per trip, and for 3 to 4 times a year.The ability to maintain a current Australian driver license, immunisation record, Working with Children Clearance (Ochre card), and National Police Clearance check.An understanding and awareness of relevant Workplace Health and Safety as well as Equal Opportunity principles and legislation along with a commitment to maintaining a healthy and safe workplace for all Menzies staff, students, volunteers and visitors.Desirable:Experience and/or relevant work experience involving evidence-based medicine, health research, clinical trials, epidemiology, public health or biostatistics.Knowledge or experience working in a hospital environment, with remote primary healthcare centres, early childhood, disadvantaged populations, or paediatric nursing.Experience in a health research environment in remote Aboriginal communities.Contact: Professor Peter Morris, Peter.Morris@menzies.edu.auWhat we offer:6 weeks annual leaveOption to increase super to 14%Attractive salary package and benefits $125,866 - $136,152 salary package (comprising gross salary $100,524 - $109,478 pa, superannuation and salary packaging benefits.Aboriginal and/or Torres Strait Islander people are strongly encouraged to apply.Closing date:  21 March 2021Applicants are required to address the selection criteria. For information on how to apply for this position and to obtain the Position Description and Selection Criteria please visit http://careers.menzies.edu.au/ or phone 08 8946 8626.  PD Clinical Trial Manager 100524 AUD Darwin

Clinical Trial Manager

Full-time contract until 30 November 2025

About Menzies:

Menzies School of Health Research is one of Australia’s leading medical research institutes dedicated to improving Indigenous, global and tropical health. Menzies has a history of over 30 years of scientific discovery and public health achievement. Menzies works at the frontline, joining with partners across the Asia-Pacific as well as Indigenous communities across northern and central Australia.

About the position:

The Deadly Ears at Discharge clinical trial is funded by the National Health and Medical Research Council to assess whether an additional assessment and support during a hospital stay by Aboriginal staff to inform the ear health discharge planning will improve health outcomes. Aboriginal children at increased risk of severe otitis media (severe OM) will be eligible.

The Clinical Trial Manager will manage the research team, undertake financial management of the clinical trial and ensure the clinical trial meets the relevant standards.

The Clinical Trial Manager will be based in Darwin. At times, however, there will be a requirement to travel remotely as a team via light aircraft and/or 4WD for up to five days, three to four times a year.

Aboriginal and/or Torres Strait Islander people are strongly encouraged to apply.

What we expect from you:

  • Manage a research team and ensure the clinical trial meets the standards of Good Clinical Practice (GCP) Guidelines, Australian Code for the Responsible Conduct of Research and National Statement on Ethical Conduct in Human Research.
  • Undertake clinical trial financial management
  • Manage administration of the independent Data Safety Monitoring Committee.
  • Collect data and report on outcomes and adverse events, ensuring that data are recorded, stored or transmitted appropriately
  • Manage research staff recruitment and provide training, supervision, mentoring and support to build your strong team.
  • Establish and maintain internal and external collaborative relationships.

Our Selection Criteria:

  • Postgraduate qualifications, or progress towards postgraduate qualifications in a relevant medical or health related field and extensive relevant experience; or extensive relevant experience and management expertise; or an equivalent combination of both.
  • Demonstrated clinical trial or clinical research management experience, including knowledge of Ethical Conduct in Research, Good Clinical Practice, participant recruitment and consent.
  • Proven experience in the development of standard operating procedures and site-specific procedures, and maintaining and monitoring compliance.
  • Experience in data and safety monitoring and reporting, writing progress reports against study milestones, and reporting to and assisting Investigator meetings
  • Experience in the recruitment, supervision, mentoring and training of staff.
  • Highly developed ability to communicate effectively, both orally and in writing, with a range of audiences including diverse cultures and a multidisciplinary team.
  • Strong negotiation and conflict resolution skills, good judgement, flexibility and resourcefulness, and the ability to maintain confidentiality.
  • Demonstrated high level experience building and maintaining strong collaborative partnerships with a diverse range of individuals and organisations.
  • Demonstrated capacity to work independently under broad direction and as part of a multidisciplinary team, maintain good organisational and time management skills, effectively prioritise workloads and meet deadlines.
  • Demonstrated financial management experience and knowledge of budget preparation, monitoring, and financial reporting and of procurement processes. Strong record keeping skills.
  • Demonstrated experience and competency with a range of computer software including the Microsoft Office Suite.
  • Willingness and ability to travel on light aircraft, on unsealed roads by 4WD to rural and remote communities as part of a team for up to five days per trip, and for 3 to 4 times a year.
  • The ability to maintain a current Australian driver license, immunisation record, Working with Children Clearance (Ochre card), and National Police Clearance check.
  • An understanding and awareness of relevant Workplace Health and Safety as well as Equal Opportunity principles and legislation along with a commitment to maintaining a healthy and safe workplace for all Menzies staff, students, volunteers and visitors.

Desirable:

  • Experience and/or relevant work experience involving evidence-based medicine, health research, clinical trials, epidemiology, public health or biostatistics.
  • Knowledge or experience working in a hospital environment, with remote primary healthcare centres, early childhood, disadvantaged populations, or paediatric nursing.
  • Experience in a health research environment in remote Aboriginal communities.

Contact: Professor Peter Morris, Peter.Morris@menzies.edu.au

What we offer:

  • 6 weeks annual leave
  • Option to increase super to 14%
  • Attractive salary package and benefits $125,866 - $136,152 salary package (comprising gross salary $100,524 - $109,478 pa, superannuation and salary packaging benefits.

Aboriginal and/or Torres Strait Islander people are strongly encouraged to apply.

Closing date:  21 March 2021

Applicants are required to address the selection criteria. For information on how to apply for this position and to obtain the Position Description and Selection Criteria please visit http://careers.menzies.edu.au/ or phone 08 8946 8626.