Senior Clinical Project Manager

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 10%

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Telix Pharmaceuticals Limited

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2015

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

Telix Pharmaceuticals Limited is a commercial-stage biopharmaceutical company dedicated to transforming the way cancer and rare diseases are diagnosed and treated. Focusing on the development and commercialization of theranostic radiopharmaceuticals, Telix utilizes targeted radiation to enhance treatment decision-making and deliver personalized therapy. With an extensive pipeline addressing areas such as prostate and kidney cancer, neuro-oncology, and musculoskeletal cancers, Telix has garnered global regulatory approvals for its lead imaging agent, Illuccix®, and is actively conducting numerous clinical trials worldwide.

📋 Description

• Manage all aspects of national and global clinical trials from protocol finalization through study closeout • Manage vendor selection, site feasibility and selection, trial timelines, budgets, resources, and vendor relationships • Forecast spending and identify opportunities to accelerate activities or shift spend • Develop integrated study management plans with the core project team • Develop and manage study documents, including protocols, informed consent, and clinical manuals • Monitor external partners for quality, timelines, and budget compliance • Ensure effective project plans are operational within applicable SOPs • Proactively manage risks and lead problem-solving and resolution efforts • Support development and maintenance of clinical SOPs and trial processes • Develop project delivery strategies for RFPs and lead bid defense preparations • Manage complex multinational, multicenter 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 cross-functional stakeholders • Train study team members and mentor CPMs • Work independently with limited supervision • Attend medical conferences and represent clinical operations through investigator engagement and presentations

🎯 Requirements

• Bachelor’s degree in life sciences required • PMP preferred • 5+ years of relevant experience in Clinical Trial Project Management required • Experience with late phase clinical trials (Phase 3 - 4, registration trials), oncology and/or radiopharmaceutical experience preferred • Excellent oral and written communication, organizational, and problem-solving skills while working under strict timelines • Team oriented mindset and ability to work with cross functional teams • Experience managing global clinical trials • Thorough knowledge of ICH Good Clinical Practice (GCP) and regulatory processes • 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 including country and site feasibility, ethics and regulatory submissions in multiple regions (APAC, EMEA, NA) • 10% travel expected

🏖️ Benefits

• Competitive salaries • Annual performance-based bonuses • Equity-based incentive program • Generous vacation • Paid wellness days • Support for learning and development