Project Manager

PTA Project Manager

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

We are looking for a PTA Project Manager to support one of our clients!!

What You Will Do:

PTA here refers to the provision of investigational product for the intent of treatment, in a non-trial setting and under the care of a physician, following participation in a trial. PTA by this definition is governed by local laws and regulations and may be provided by established regulatory mechanisms such as early access, named patient programs, and other pre-approval access and managed access programs.

• Develop and manage timelines and budgets for post-trial access (PTA) programs supporting investigational products prior to regulatory approval
• Ensure compliance with regulatory requirements and company Policies/SOPs  
• 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 requests for investigational product access through PTA programs, ensuring timely and compliant processing
• Manage vendor contracting and deliverables in support of PTA/continued access program execution
• Utilize PTA tools, templates, and systems to ensure accurate tracking and reporting of investigational access programs
• Monitor quality, KPIs, and program performance; identify issues and escalate as needed
• Communicate PTA program status, risks, and updates to stakeholders
• Identify risks and implement mitigation strategies specific to investigational product access and program continuity; capture lessons learned and best practices
• Ensure inspection readiness, maintain complete and accurate documentation, and perform quality checks for PTA programs
• Support other PTA/continued access activities and programs, as assigned

You are:

• BS/BA (or equivalent experience)
• 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.

What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• 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.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply