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

The Clinical Project Manager (CPM) is responsible to support and oversee the day-to-day responsibilities of multiple early phase regional clinical trials from protocol conception, start-up through the clinical study report, including all aspects of project document development, budget, safety, and quality in an environment where problem solving, critical thinking, teamwork and flexibility are vital to success. The CPM will work closely with CROs and/or third-party vendors and closely collaborate with cross-functional internal and external stakeholders to ensure adherence to GCP, SOPs, and FDA/ICH guidelines and ultimate delivery of high-quality data within the defined timelines and approved budget. The CPM ensures completion of study deliverables and proactively identifies and resolves clinical project issues.

In addition to study execution responsibilities, the CPM will dedicate an appropriate amount of time to serving as a Site Relationship Manager for Telix's key clinical research sites and investigators. This role will act as the primary point of contact for assigned strategic sites, ensuring a seamless experience for Investigators across all Telix interactions.

Key Accountabilities

Clinical Project Manager:

Support the planning and setup, maintenance and closeout phases of multiple concurrent clinical research studies
Proactively managing all aspects of the trial process including vendor selection, site feasibility and selection, trial clinical timelines, clinical budgets, resources, and vendor relationships
Provide day-to-day study management including, but not limited to oversight of CRO, study vendors and investigational sites in coordination with various cross-functional team members and study team.
Monitoring all work performed by the external partners to ensure quality of the service with respect to mutually agreed timelines and budget.
Support the drafting, review and updating of documents related to clinical development such as Clinical Trial Protocols, Informed Consent Forms, Investigator’s Brochure, Laboratory Manual, IMP Handling Manual, etc.
Ensuring effective project plans are in place and operational for each trial within trial appropriate SOPs
Identify and mitigate risks and apply strong problem-solving skills to ensure timely resolution of all study related issues
Manage, facilitate and/or monitor the completion of interdisciplinary project tasks including site monitoring/audits, CRF and database development / revision, data collection, patient safety / AE management, document management, statistical analysis / final report writing, and study close out.
Management of small or medium-sized projects or regional leadership of complex multi-center clinical research projects
Oversee the study specific Trial Master File (TMF) and assist with periodic audit of the TMF
Perform any other tasks/duties as assigned by management

Site Relationship Manager:

Serve as the primary Telix representative and trusted partner for assigned strategic clinical trial sites and institutions.
Develop and maintain relationships with Principal Investigators, Clinical Trial Unit Managers, nuclear medicine department, and study coordinators.
Execute on site-specific strategic partnership plans put in place by Global Clinical Operations Leadership team.
Act as the single point of contact for strategic sites regarding all Telix-related activities, including clinical trials, feasibility opportunities, investigator-initiated research, finances, training, and operational support.