Senior Clinical Project Manager

Telix Pharmaceuticals (AMER)

About The Position

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 Senior Clinical Project Manager (SCPM) reports to the Senior/Director of Clinical Operations who bears primary responsibility for the execution of Telix’s clinical trials. The SCPM is responsible for the successful execution of national and global clinical trials (early phase to registration) from protocol conception, start-up through the clinical study report, including all aspects of project document development, budget, safety, quality, and team management in an environment where problem solving, critical thinking, teamwork and flexibility are vital to success. The SCPM ensures completion of study deliverables and proactively identifies and resolves clinical project issues.

Requirements

Bachelor’s degree in life sciences required, PMP preferred
5+ years of relevant experience in Clinical Trial Project Management required
Excellent oral and written communication, organizational, and problem-solving skills while working under strict timelines.
Team oriented mindset and demonstrates ability to work with cross functional teams.
Experience managing global clinical trials.
Thorough knowledge of ICH Good Clinical Practice (GCP) and regulatory processes.
Demonstrated ability to pivot study strategy quickly and lead teams in the right direction.
Strong analytical, organisational, planning, decision making, negotiation, and conflict management skills.
Fluent in Microsoft Office suite (Word, Excel, SharePoint, Teams, etc.) and experienced in working in mainly electronic record-keeping environment.
Demonstrated leadership skills and ability to cultivate development of others
Start-up experience (country and site feasibility, ethics & regulatory submissions in multiple regions (APAC, EMEA, NA))

Nice To Haves

Experience with late phase clinical trials (Phase 3 - 4, registration trials), oncology and/or radiopharmaceutical experience preferred.

Responsibilities

Proactively managing all aspects of the trial process including vendor selection, site feasibility and selection, trial timelines, budgets, resources, and vendor relationships from protocol finalization through to study closeout.
Forecast and identify opportunities to accelerate activities to bring spend forward or identify if spend will shift.
Independently develop integrated study management plans with the core project team.
Developing and managing all study-related documents such as study protocol, informed consent, clinical manuals, and implementing quality standards.
Monitoring all work performed by the external partners to ensure quality of the service with respect to mutually agreed timelines and budget.
Ensuring effective project plans are in place and operational for each trial within trial appropriate SOPs.
Managing risks proactively and leading problem solving and resolution efforts
Support the development and maintenance clinical SOPs & trial process’ as required.
Developing project delivery strategy for RFPs. Lead in bid defense preparations. Understand project strategy and translate the agreed upon approach.
Management of complex multi-national, multi-center clinical research projects
Develop patient recruitment strategies
Conduct contract and budget negotiations with sites and vendors
Communicate trial status, issues, and mitigations to leadership and relevant cross-functional stakeholders
Train study team members and act as mentor for CPMs
Work independently with limited supervision
Attend medical conferences and represent clinical operations through investigator engagement and/or presentations