Sr. Clinical Project Manager

See Yourself at Telix

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