Telix Pharmaceuticals is seeking a Clinical Project Manager to support the international roll-out of their approved prostate cancer imaging agent and advance their portfolio of late clinical-stage products. The CPM will oversee day-to-day responsibilities of multiple early phase regional clinical trials from protocol conception to study report, ensuring completion of study deliverables and adherence to GCP, SOPs, and FDA/ICH guidelines.
Requirements
- 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 oversight of CRO, study vendors and investigational sites in coordination with various cross-functional team members and study team
- Monitor 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.
- Ensure 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
- 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
Benefits
- Competitive salaries
- Annual performance-based bonuses
- Equity-based incentive program
- Generous vacation
- Paid wellness days
- Support for learning and development
