Clinical Trials Associate

at  Telix Pharmaceuticals APAC

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.
The Clinical Trial Associate (CTA) supports clinical studies and the Clinical Operations Department, in managing various administrative tasks such as generation of agenda and minutes, maintaining study tracking, eTMF management, filing and quality reviews of study documents as well as participating in process improvement initiatives across the department. Strong candidates will bring knowledge and experience in the fundamental aspects of trial and study site management, vendor management, and experience in the full cycle of study from start- up to close out.

• Assists Clinical Project Managers (CPMs) with Sponsor oversight, study specific documentation review and QC including review of ICF, study plans, study reference manuals, eCRF, etc.
• Support IITs (Investigator Initiated Trials) by providing oversight and operational support, including but not limited to clinical supply forecasting and management, reoccurring meeting participation and preparation.
• Assist with creation and maintenance of study metrics trackers, tools and reports.
• Assist in co-ordination and tracking of Investigator and third-party payments.
• Ensure required study documents are submitted to the study (electronic) trial master file ((e)TMF).
• In collaboration with the CPM, conduct eTMF reviews for in-house studies.
• Create Investigator Site File (ISF) for in-house studies.
• Manage (e)TMF and study documents to meet GCP/ICH and internal guidelines for records retention.
• Acts a CLM Super user and facilitates contracts execution and contract management in the system
• Assists CPMs with Sponsor oversight of CRO-held eTMFs periodic audit and findings resolution.
• Assists with customization of CDA, clinical site contracts & budgets, when applicable.
• Assist CPMs and clinical team with Investigator Meeting coordination and activities preparation.