Key Facts

Remote From:

Full time

Senior (5-10 years)

English

Hard Skills

Clinical Trial Planning Risk Analytics Website Monitoring Data-Driven Decision Making Data Sharing Web Administration Performance Management Change Management Compliance Management Stakeholder Communications +6 more

Other Skills

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Collaboration
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Communication
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Adaptability
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Teamwork
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Critical Thinking
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Organizational Skills
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Social Skills
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Growth Mindedness
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Problem Solving

Roles & Responsibilities

Minimum of 6 years of experience in the pharmaceutical or CRO industry
At least 2 years of experience in Site Monitoring / Site Monitoring Management, Risk-Based Monitoring, or Monitoring Excellence roles
Robust understanding of drug development and clinical trial execution processes
Knowledge of industry regulatory standards including 21 CFR Part 11, ICH E6 (GCP)

Requirements:

Maintain high quality, consistency, and compliance with Sponsor procedures across studies
Recommend monitoring process adjustments based on experience, feedback, and data-driven trends in site monitoring activity assessments
Identify and share best practices, case studies, and process improvement opportunities to promote continuous improvement and consistency with Sponsor’s site monitoring processes
Act as a change agent, subject matter expert, and point of contact for site monitoring and site management concepts with Sponsor study teams

ICON plc

Pharmaceuticals

About ICON plc

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.

Company type: XLarge

Industry: Pharmaceuticals

Founded: 2018

Company size: 10001

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Job description

RBM Site Monitoring Lead

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

As a RBM Site Monitoring Lead at ICON, you will manage clinical trial operations activities, supporting your team and stakeholders to deliver high-quality outcomes across our clinical programs.

What You Will Do:

Maintain high quality, consistency, and compliance with Sponsor procedures across studies
Recommend monitoring process adjustments based on experience, feedback, and data-driven trends in site monitoring activity assessments
Identify and shares best practices, case studies, and process improvement opportunities to promote continuous improvement and consistency with Sponsor’s site monitoring processes
Act as a change agent, subject matter expert, and point of contact for site monitoring and site management concepts with Sponsor study teams
Support and participates in internal and external audits and inspections as requested

Your Profile:

Pragmatic and comfortable with evolving processes; willing to drive and support change
Excellent teamwork, organizational, interpersonal, and problem-solving skills
Clear and collaborative communication style, with demonstrated ability to think critically, collaborate effectively and influence without authority
Ability to embrace and demonstrate a growth mindset focused on diversity and inclusion

Required qualifications and experience:

Minimum of 6 years of experience in the pharmaceutical or CRO industry
Minimum of 2 years of experience in Site Monitoring / Site Monitoring Management, Risk-Based Monitoring, or Monitoring Excellence roles
Robust understanding of drug development and clinical trial execution processes
Knowledge of industry regulatory standards including 21 CFR Part 11, ICH E6 (GCP)
May require up to 50 % travel, potentially including overnight and international travel

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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised 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