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March

Clinical Trial Manager

Telix Pharmaceuticals Limited - Melbourne, VIC

Health, Medical & Pharmaceutical
Source: uWorkin

JOB DESCRIPTION

Telix Pharmaceuticals is searching for a Clinical Trial Manager to fill this newly created position and contribute to the achievement of the Group’s strategic clinical goals. Working within the clinical team, the successful candidate will assist in the organisation and management of the clinical trials of all Telix products. The role will hold responsibility for the planning, conduct performance and closure of a clinical trial/study ensuring that activities are conducted in compliance with Telix quality standards and regulations, forecasted timelines, milestones and budget. 

The position is based in Melbourne (Australia) and will report to an Australian-based clinical project manager though extensive interaction with key staff in the USA and other international locations will be required. Some travel is also expected.

Key accountabilities will also include:

  • Implementation of all actions necessary for the successful start-up, execution and completion of clinical studies (Phase 1 to Phase 4) in accordance with company SOPs, CFR, ICH and GCP guidelines.
  • Working collaboratively with the clinical team to develop work plans (Data Management Plan, Safety Plan, Monitoring Plan, Project Plan, etc.)
  • Creating and implementing study-specific clinical monitoring tools and clinical documents (Protocol, ICF, CRF, CSR).
  • Creating and managing the clinical trial budget.
  • Managing clinical research organisations to start, execute and successfully complete clinical trials.
  • Identifying risks and issues and proposing/implementing corrective actions.
  • Collecting, processing, organising and archiving study documents.

To be considered, candidates should hold a Bachelors’ degree (or higher) in a relevant discipline and have demonstrable experience in clinical project management. A strong understanding of phase 1 – 4 clinical trials and good working knowledge of the drug development process are mandatory! Experience in a pharmaceutical/biotechnology company and/or clinical research organisation is also a must.

Agency support is not required for this role and no submissions will be considered.

Melbourne, VIC

Health, Medical & Pharmaceutical




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