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Associate Director – Clinical Operations
Telix Pharmaceuticals Limited. Ensure clinical-stage programs meet objectives within timelines, budget, and quality standards .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing clinical trials throughout their lifecycle, including operational planning, budget oversight, and compliance with GCP and ICH guidelines. Proven ability to lead cross-functional teams and develop effective risk management and recruitment strategies.
Highest-signal resume keywords
Clinical Trial ManagementGCP And ICH Guidelines KnowledgeCRO/Vendor ManagementBudget Preparation And ForecastingRisk Management Planning
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Study ExecutionCase Report Form DesignTrial Master File MaintenanceKPI Development And ManagementOperational PlanningRegulatory ComplianceAudit ReadinessContingency PlanningBudget OversightStudy Timeline Management
Soft Skills
Strong CommunicationCollaborationAdaptabilityEthical BehaviorContinuous Learning
Industry Keywords
Clinical OperationsClinical TrialsInvestigator ManagementSOP DevelopmentMultidisciplinary Team Management
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Ensure clinical-stage programs meet objectives within timelines, budget, and quality standards
- Plan and execute clinical studies from startup through conduct, reporting, and close-out
- Lead and manage integration of internal, development-partner, and CRO project-team activities
- Oversee clinical trials from inception to completion
- Provide leadership and line management to clinical operations staff
- Develop global subject/patient recruitment plans and communicate with study principal investigators
- Oversee CRO/vendor management and develop key performance indicators
- Create contingency and risk management plans
- Support clinical project managers within and across programs
- Prepare budgets, study timelines, forecasts, and variance analyses
- Monitor clinical studies through communication with CROs and investigator sites
- Coordinate cross-functional teams for optimal clinical-trial execution
- Review and complete study-related plans and systems
- Participate in Case Report Form design and user acceptance testing
- Contribute to protocol and informed-consent development from an operational feasibility perspective
- Oversee study budgets, contracts, payments, and accruals
- Maintain the Trial Master File and inspection readiness
- Support audit and inspection activities
- Partner with regulatory and medical teams on safety management and monitoring processes
- Initiate clinical change-control processes
- Contribute to SOP development and department infrastructure improvements
Requirements
What you’ll need- Experience and capability to lead and manage clinical trials across their lifecycle
- Operational planning and execution of clinical studies
- Knowledge of GCP and ICH guidelines
- Knowledge of regulatory requirements and company SOPs
- Experience managing multidisciplinary internal and external teams
- CRO/vendor identification, procurement, selection, and operational management experience
- Experience developing and managing KPIs
- Experience with Case Report Form design and user acceptance testing
- Experience developing contingency and risk management plans
- Experience preparing budgets, study timelines, and forecasts
- Experience overseeing investigator and vendor contracts, budgets, and payments
- Experience with Trial Master File setup, maintenance, close-out, and audit readiness
- Experience supporting audits and inspections
- Experience with clinical change control processes
- Experience providing line management, mentoring, and staff development
- Ability to collaborate with Clinical, Data Management, Medical Writing, Biostatistics, CMC, Pharmacovigilance, Regulatory, Program Management, CROs, and other stakeholders
- Strong communication, collaboration, adaptability, ethical behavior, and continuous learning capabilities
Benefits
Comp & perks- Annual performance-based bonuses
- Equity-based incentive program
- Generous vacation
- Paid wellness days
- Support for learning and development
- Hybrid and remote work arrangements