Clinical Data Manager

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. 

See Yourself at Telix

Clinical Data Manager is responsible to ensure the integrity, accuracy and compliance of clinical trial data with study and regulatory requirements, SOPs and CDISC data standards. CDMS will be responsible for overseeing data quality for Telix clinical trials, ensuring Electronic Data Capture (EDC) development per study requirements, overseeing data cleaning activities and managing external data transfers. They will lead data management activities for assigned Telix clinical trials and manage deliverables per timelines, from study start up through database lock and study close-out. They will ensure optimized data collection, flow and access across EDC and non-EDC sources.

Key Accountabilities:

• Will act as primary data management SME for assigned Telix clinical trials.
• Oversee and support all activities for EDC build including Data Management Plan (DMP), Data review plans, EDC build specifications, User Acceptance Testing (UAT), electronic Case Report Forms (eCRF) Completion Guidelines and other activities as needed.
• Oversee data entry and cleaning activities for assigned Telix clinical trials.
• Oversee completeness of data management documentation for eTMF.
• Liaises with external vendors to support timelines, deliverables and data transfers.
• May assist with review of data related deliverables.
• May assist in development and review of protocol and Statistical Analysis Plan (SAP).
• Support audits, inspections, study kick off meetings as needed.
• Ensure compliance with Good Clinical Practice (GCP), CDISC standards and other regulations as applicable.
• Support internal Clinical Data Management initiatives.

Position Requirements:

Education and Experience: 

• Bachelor’s degree in Health Information Management, Life Sciences or equivalent work experience. Advanced degree preferred.
• 3+ years of experience in clinical trial data management with a minimum of 1 year experience in leading data management activities independently for complex global clinical trials REQUIRED.