Sr. Clinical Project Manager

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

This role serves as the primary Sponsor operational lead for assigned clinical studies, driving cross-functional alignment across Clinical, Medical, Regulatory, Data Management, Safety, Clinical Supply, CMC, Quality, and external partners. The Senior Clinical Project Manager is responsible for leading the planning, execution, oversight, and delivery of sponsor-led clinical trials in accordance with the protocol, applicable regulations, ICH-GCP, company SOPs, quality standards, timelines, and budget.  The Sr. CPM provides proactive oversight of CROs, vendors, investigative sites, study milestones, risks, budgets, and deliverables from study start-up through closeout including clinical study report completion. The role requires strong clinical trial operations expertise, sponsor-side accountability, critical thinking, vendor governance, issue escalation and resolution, and the ability to lead study teams in a complex, fast-paced, and highly regulated environment. This role reports to the Senior Director, Clinical Operations. 

Key Accountabilities:

• Serve as the sponsor operational lead for assigned clinical trials.
• Lead cross-functional study teams and drive alignment across Clinical Operations, Medical, Regulatory, Data Management, Biostatistics, Pharmacovigilance/Safety, Clinical Supply, Quality, Legal, Finance, and external partners.
• Provide sponsor oversight of selected CROs, vendors, and external partners, including review of performance, quality, deliverables, study metrics, issue trends, escalation pathways, and corrective/preventive actions.
• Develop, maintain, and manage integrated study plans, timelines, risk management plans, communication plans, monitoring oversight plans, recruitment plans, and other study-specific operational plans.
• Oversee country and site feasibility, site selection, study start-up, regulatory and ethics submissions, site activation, enrollment readiness, and ongoing site performance in collaboration with internal teams and external partners.
• Monitor study progress against key milestones, enrollment targets, budget, forecast, and deliverables; proactively identify risks, develop mitigation strategies, and escalate issues appropriately to leadership and governance forums.
• Manage study budgets, forecasts, purchase orders, invoices, accruals, change orders, and vendor/site financial oversight in partnership with Finance, Legal, Procurement, and functional stakeholders.
• Develop Sponsor required study documents while providing sponsor input into study documents, including protocols, informed consent forms, study manuals, monitoring plans, vendor plans, training materials, newsletters, and operational guidance documents developed by any vendor.  
• Ensure quality oversight and inspection readiness by supporting TMF/eTMF completeness, protocol deviation oversight, issue management, audit responses, CAPA follow-up, and compliance with sponsor procedures and regulatory expectations.
• Partner with study teams and sites to support patient recruitment and retention strategies, remove operational barriers, and ensure enrollment activities remain ethical, compliant, and aligned with trial objectives.
• Prepare and communicate study status updates, dashboards, metrics, risks, decisions, and mitigation plans to internal leadership, governance committees, and cross-functional stakeholders.
• Lead study team meetings, vendor governance meetings, risk reviews, lessons learned discussions, and operational decision-making forums to promote accountability and timely execution.
• Represent Clinical Operations in internal and external meetings, including investigator meetings, vendor meetings, conferences, audits, inspections, and cross-functional governance discussions, as appropriate. 

Position Requirements

Education and Experience: 

• A minimum of a bachelor’s degree in life sciences, PMP preferred.
• 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 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, organizational, 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))

Key Capabilities:

• Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
• Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
• Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
• Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
• Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills

At Telix, we believe everyone counts, we strive to be extraordinary, and we pursue our goals with determination and integrity. You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development. 

Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics. 

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