Project Manager - Post Trial Access

Clinical Trial Manager - Post Trial Access

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

As a Project Manager - Post Trial Access at ICON, you will be responsible for leading and coordinate project activities, ensuring that projects are delivered on time, within budget, and to the highest quality standards.

What You Will Do:

Your focus will be on coordinating project and programme management delivery, resolving issues, and developing team capability.

Key responsibilities include:

• 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

Your Profile:

You will have solid project and programme management experience, with the ability to manage competing priorities and develop your team.

Required qualifications and 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

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Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

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

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

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