Clinical Legal Escalation Reviewer

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise. As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

As a Legal Escalation Reviewer at ICON, you will oversee site contracting performance and strategy across a defined portfolio of studies or customers. You will ensure contracting is delivered predictably, efficiently, and in line with business and customer expectations.

What You Will Do:

• You will manage day-to-day contract management activities, supporting your team to deliver quality outcomes.
• Manage and may lead the day-to-day operations within relevant support function to ensure completion per established goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
• This includes effective communication and coordination with key business stakeholders (e.g., study teams) to support timely completion of both drug and non-drug program goals and objectives.
• Responsible for implementation of standards for designated functional areas.
• Manage and provide operational support of the global study operating model inclusive of development and maintenance/optimization of various CO business processes and service provider related operating models (CRO, IRT, Central Lab).
• Manage the sustainability and optimization of internal and external business process standards for Clinical Operations.
• Provide oversight and direction to team members for contract escalations.
• Work with site contract team to proactively identify, risk-manage, including escalation and resolve issues that arise with clinical site contracts.
• Drive and/or contribute to the development and/or continuous update(s) to functional SOPs, Astellas Global Contract Negotiations Playbook and other relevant core processes and tools.
• Serve as liaison to collaborate between site contract negotiators and designated legal partners (as needed) to support development or update to global templates and processes.

Your Profile:

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

Required qualifications and experience:

• BA/BS degree with ≥5 years of experience in pharmaceutical related drug development or direct equivalent experience or advanced degree.
• Must have knowledge of clinical trial conduct, including multi-center, global trials.
• Must have strong knowledge of ICH/GCP guidelines and regulatory requirements.
• Good understanding of the regulatory, legal and data privacy issues affecting the pharmaceutical industry, including GDPR as it relates to the core and country templates.
• Experience with development & implementation of process improvement related initiatives.
• Strong ability to grasp regulatory and legal issues quickly, exhibit strong analytical problem solving and decision-making skills, exercise sound judgment and provide practical and constructive legal advice.
• Strong negotiation and communication skills (both oral and written). Ability to communicate legal issues in a clear and understandable manner.
• Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.

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.