Remote Life Science Jobs, Clinical Project Manager Job at Telix Pharmaceuticals, Apply Online
Clinical Project Manager
APAC – Remote
Updated: Thursday 12 December 2024
About the Company:
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 needs in oncology and rare diseases.
Job Summary:
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. This is a 12-month fixed-term position.
What You’ll Do:
- Proactively manage all aspects of the trial process, including Vendor selection, Site feasibility and selection, Trial clinical timelines, Clinical budgets and resources, Overseeing vendor relationships
- Manage and monitor CRO activities.
- Develop 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
- 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, Study closeout
- Monitor all work performed by external partners to ensure quality of 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.
- Manage 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:
Education: Bachelor’s degree in life sciences required
Experience:
- 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
Skills and Knowledge:
- Thorough knowledge of ICH Good Clinical Practice (GCP) and regulatory processes
- Fluent in Microsoft Office suite (Word, Excel, SharePoint, Teams, etc.)
- Experienced in working in mainly electronic record-keeping environments
- 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
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