Clinical Trials Project Manager / Senior Clinical Trials Project Manager

  • Full Time
  • Brisbane based location
  • Attractive salary packaging & superannuation options

About QIMR Berghofer:

QIMR Berghofer is a world-leading translational medical research institute focused on improving health by developing new diagnostics, better treatments and prevention strategies, specifically in the areas of cancer, infectious diseases, mental health and complex disorders. Based in Herston, Brisbane and working in close collaboration with clinicians and other research institutes, QIMR Berghofer is home to more than 600 scientists, students and support staff.

About Clinical Tropical Medicine:

Clinical Tropical Medicine investigates how parasites such as the malaria parasite, hookworm, threadworm and scabies cause disease and how they become resistant to drugs used to treat them. The group also identifies new drugs and drug targets, and develops novel diagnostic techniques. A program of human clinical trials testing malaria drugs and vaccines involves infecting human volunteers with malaria. As such, a comprehensive suite of documentation needs to be prepared for each study and careful project management is required.


Role Purposes / Responsibilities:

  • Manage clinical trial projects ensuring that they are conducted efficiently, to the required standard and within proposed time frames.
  • Define tasks effectively, and identify, schedule, and prioritize activities, as well as monitor and report on projects’ progress.
  • Create, implement and maintain documentation and procedures for clinical trials, ensuring compliance with relevant regulations (ICH GCP, TGA, HREC, Safety, QIMR Berghofer’s policies and procedures for Clinical Research and other organisational procedures). These include: assisting in the design of clinical trial protocols, clinical trial forms/templates and associated documents and procedures for HREC submissions and amendments.
  • Write protocols, clinical study reports and grant applications for supervisors, collaborators and external organisations.
  • Liaise with members of the CTM team, clinicians, clinical trial coordinators, internal and external collaborators, to ensure studies progress on schedule and adequate resources are allocated to complete the trial within specified deadlines and budget.
  • Monitor clinical trial activities to ensure compliance with the Institute’s ethical and biosafety requirements and other legislative requirements.
  • Ensure work practices comply with the requirements of the Work Health and Safety Act, related legislative requirements and the Institute’s WH&S policies and procedures.


About You:

To be successful in this role you will require:

Essential

  • Highly motivated individual with a minimum of a Bachelor’s degree in Biomedical Science or other relevant discipline.
  • Experience in clinical trial project management, particularly in planning and implementation of complex projects involving partners in multiple disciplines including regulatory authorities.
  • High level written communication skills with experience in preparing clinical study reports and clinical trial protocols, and analysing information from multiple sources.
  • Excellent organisational and time management skills.
  • High level attention to detail, particularly in handling data and record keeping.
  • Excellent verbal and interpersonal communication skills.
  • Detailed knowledge of ICH Guidelines and GCP.


Desirable
  • Experience in managing early phase clinical trials.
  • At least 5 years’ experience in clinical trial project management

What We Offer:

  • Salary Packaging
  • Bonus Superannuation
  • State of the art facilities
  • Stimulating work setting focussed on cutting edge medical research
  • Supportive/collaborative team environment

Salary package range is $96,326 - $124,996 (including Superannuation of up to 15.75% and annual leave loading). This is a full-time fixed term appointment for 12 months.

Click on the “Apply” button on the positions vacant page.

Applications should address the selection criteria and include curriculum vitae, proof of qualifications, and the names and contact details of three professional referees.

10 August 2017
Contact Nicole Williams on 07 3362 0462