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Senior Clinical Project Manager
Telix Pharmaceuticals Limited. Serve as the sponsor operational lead for assigned clinical trials .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Clinical Trial Project Management, with a strong focus on late phase clinical trials, regulatory compliance, and cross-functional team leadership. Proficient in developing operational plans, managing study budgets, and ensuring quality oversight throughout the clinical trial process.
Highest-signal resume keywords
Clinical Trial Project ManagementICH Good Clinical Practice (GCP)Regulatory ProcessesOncology ExperienceBudget Management
ATS Keywords
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Hard Skills
Clinical Trial ManagementStudy Plan DevelopmentRisk ManagementSite SelectionEnrollment ReadinessProtocol DevelopmentData ManagementVendor OversightFinancial OversightPatient Recruitment Strategies
Soft Skills
Excellent CommunicationOrganizational SkillsProblem-Solving SkillsTeam Oriented MindsetLeadership Skills
Tools & Technologies
Microsoft Office SuiteElectronic Record-Keeping SystemsSharePointTeams
Industry Keywords
Clinical TrialsPhase 3 TrialsPhase 4 TrialsRegulatory SubmissionsSite ActivationAudit ResponsesCAPA Follow-UpGlobal Clinical TrialsCross-Functional TeamsStudy Milestones
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- Competitive salaries
- Annual performance-based bonuses
- Equity-based incentive program
- Generous vacation
- Paid wellness days
- Support for learning and development