Clinical Project Manager - Post Trial Access

• Develop and manage timelines and budgets for post-trial access (PTA) programs supporting investigational products prior to regulatory approval
• Lead cross-functional teams and serve as primary program contact for PTA/Continued Access programs
• Populate PTA templates and tools with program-specific information related to investigational product access decisions and implementation
• Drive development and finalization of core program documents (e.g. PTA Treatment Guidelines, PTA ICF, agreements and contracts)
• Drive decision-making, including selection of appropriate regulatory mechanisms, supply strategy, and safety reporting, in collaboration with cross-functional stakeholders
• with support as needed
• Ensure alignment across PTA program decisions, documentation, plans, and implementation
• Provide forecasting and ensure investigational supply strategies are developed and executed, in collaboration with Supply Chain, to facilitate uninterrupted patient access to investigational products
• Manage vendor contracting and deliverables in support of PTA/continued access program execution

• Experience in clinical research or biopharmaceutical operations
• including 2+ years leading global, multi-regional PTA programs across the lifecycle, for investigational products prior to regulatory approval
• comparable experience leading expanded access/compassionate use programs or significant experience contributing to PTA or EAP may be considered
• General understanding of regulatory frameworks governing pre-approval and continued access to investigational products, ICH GCP, and ethical frameworks of clinical research
• Demonstrated ability to manage mild to moderately complex, multi-region PTA programs involving investigational products with a degree of operational and regulatory complexity, with minimal supervision
• Proven experience collaborating effectively
• influencing stakeholders across functions and levels
• Evidence of strong project management skills
• including managing competing priorities and solving operational challenges in clinical or investigational program environments
• Successful history of working independently in a global environment
• Experience with automating processes, process mapping and/or certification in Lean or Six Sigma would be considered an advantage, though it is not a mandatory requirement

Experience with automating processes, process mapping and/or certification in Lean or Six Sigma would be considered an advantage

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others