Clinical Project Manager

2 weeks ago

Melbourne, Victoria, Australia Telix Full time

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 Project Manager is responsible for the successful execution of regional clinical trials (mainly early phase) 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 ensures completion of study deliverables and proactively identifies and resolves clinical project issues.

What you'll do

  • Proactively manage all aspects of the trial process including vendor selection, site feasibility and selection, trial clinical timelines, clinical budgets, resources, and oversee vendor relationships
  • Manage and monitor CRO activities
  • Developing integrated study management plans with the core project team
  • 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. 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.
  • Monitor all work performed by the external partners to ensure quality of the service with respect to mutually agreed timelines and budget.
  • Ensure effective project plans are in place and operational for each trial within trial appropriate SOPs.
  • Manage risks proactively and lead problem solving and resolution efforts
  • Management of small or medium-sized projects or regional leadership of complex multi-center clinical research projects
  • Develop and implement a clinical program/study operational plan

About you

  • Bachelor's degree in life sciences required
  • 3+ years of relevant experience in Clinical Trial Project Management
  • Experience with early phase clinical trials (Phase 1 - 2), oncology and/or radiopharmaceutical experience preferred
  • Thorough knowledge of ICH Good Clinical Practice (GCP) and regulatory processes
  • Fluent in Microsoft Office suite (Word, Excel, SharePoint, Teams, etc.) and experienced in working in mainly electronic record-keeping environment.
  • Regional start-up experience (site feasibility, ethics & regulatory submissions)
  • Demonstrated ability to pivot study strategy quickly and lead teams in the right direction
  • Experience in conflict resolution, clinical project management practice, risk management, and an understanding of project financials
  • Multi-study experience managing early through late stage clinical trials

At Telix, we believe everyone counts, we strive to be extraordinary, and we pursue our goals with determination and integrity. You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.

Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.

VIEW OUR PRIVACY POLICY HERE

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