Clinical Legal Escalation Reviewer

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.

Key responsibilities include:

• 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) and/or
• Manage the sustainability and optimization of internal and external business process standards for Clinical Operations and/or
• Provide oversight and direction to team members for contract escalations
• Works 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.
• Serves as liaison to collaborate between site contract negotiators and designated legal partners (as needed) to support development or update to global templates and processes to help ensure timely, proactive, strategic, best-in-class legal advice and support, taking into account objectives of the organization, and the unique and varying global, regional and local legal and regulatory requirements in a risk-balanced manner in order to effectively minimize and mitigate risk to the business.

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.

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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