Senior Clinical Project Manager

🔥 33 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

• Serve as the sponsor operational lead for assigned clinical trials • Lead cross-functional study teams across Clinical Operations, Medical, Regulatory, Data Management, Biostatistics, Safety, Clinical Supply, Quality, Legal, Finance, and external partners • Provide sponsor oversight of CROs, vendors, and external partners • Develop and manage study plans, timelines, risk-management plans, communication plans, monitoring oversight plans, recruitment plans, and other operational plans • Oversee country and site feasibility, site selection, study start-up, regulatory and ethics submissions, site activation, enrollment readiness, and site performance • Monitor milestones, enrollment targets, budgets, forecasts, risks, and deliverables; develop mitigation strategies and escalate issues • Manage study budgets, forecasts, purchase orders, invoices, accruals, change orders, and vendor/site financial oversight • Develop and provide sponsor input into study documents, including protocols, informed consent forms, study manuals, monitoring plans, vendor plans, training materials, newsletters, and operational guidance • Ensure quality oversight and inspection readiness through TMF/eTMF completeness, protocol deviation oversight, issue management, audit responses, CAPA follow-up, and compliance • Support patient recruitment and retention strategies and remove operational barriers • Prepare and communicate study updates, dashboards, metrics, risks, decisions, and mitigation plans • Lead study team meetings, vendor governance meetings, risk reviews, lessons learned, and operational decision-making forums • Represent Clinical Operations in investigator meetings, vendor meetings, conferences, audits, inspections, and governance discussions

🎯 Requirements

• A minimum of a bachelor’s degree in life sciences • At least 5 years of relevant experience in Clinical Trial Project Management • 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 • Demonstrated ability to pivot study strategy quickly and lead teams • Strong analytical, organizational, planning, decision-making, negotiation, and conflict-management skills • Fluent in Microsoft Office suite (Word, Excel, SharePoint, Teams, etc.) and experienced in electronic record-keeping environments • Demonstrated leadership skills and ability to cultivate development of others • Start-up experience, including country and site feasibility and ethics and regulatory submissions in multiple regions (APAC, EMEA, NA)

🏖️ Benefits

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