Clinical Quality Compliance Lead

PRA HEALTH SCIENCES; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

A leading clinical research organization is seeking a Clinical Quality Compliance Lead to oversee adherence to processes and compliance in clinical trials. The role involves evaluating trial processes, managing compliance activities, and providing feedback on documentation quality. Ideal candidates will have extensive experience in clinical research and a strong understanding of GCP regulations. Join this dynamic team to facilitate high performance and offer impactful contributions to drug development.

Benefits

Health insurance options

Retirement planning options

Life assurance

Annual leave entitlements

Global Employee Assistance Programme

Flexible country-specific benefits

Qualifications

• Minimum of 4+ years of clinical research experience required.
• Proven track record in managing clinical trial delivery or compliance activities.
• Solid knowledge of GCP compliance processes.

Responsibilities

• Evaluate clinical trial processes for compliance with documentation.
• Develop and maintain KPIs and dashboards for quality monitoring.
• Ensure compliance with Learning Curricula and GXP requirements.

Skills

Problem Solving

Negotiations

Team Building

Regulatory Knowledge

Education

BSc, MSc, or equivalent in a scientific field

Tools

Microsoft Office

Job description

Overview

As a Clinical Quality Compliance Lead, you will join the world’s largest and most comprehensive clinical research organisation, powered by healthcare intelligence.

Responsibilities

What you will be doing:

• Perform proactive and routine evaluation of clinical trial processes to ensure adherence to process and procedural documentation through documentation review and active engagement with study team representatives.
• Help develop and maintain KPIs, metrics, and dashboards to monitor process quality and compliance.
• Provide near real-time feedback on study process and documentation quality, as well as team performance and understanding of evaluated processes.
• Ensure compliance with Learning Curricula, corporate, and GXP requirements.
• Represent GCP Compliance in meetings as needed.

Qualifications

You are:

• Minimum of 4+ years of clinical research experience in the pharmaceutical or biotechnology field.
• Solid knowledge of drug development, clinical trial management, and GCP compliance processes.
• Proven track record in managing projects related to clinical trial delivery or compliance activities for drug development programs.
• Experience in problem solving, negotiations, and collaborative team building with non-direct reports and stakeholders.
• Solid knowledge of regulatory requirements governing clinical trials, industry best practices, and related documentation standards.
• BSc, MSc, or equivalent in a scientific field.
• Proficient in computer software such as Microsoft Office for general use, project management, and presentations.
• Ability to resolve conflicts constructively.

What ICON can offer you: Our success depends on the quality of our people. We prioritize building a diverse culture that rewards high performance and nurtures talent. Along with a competitive salary, ICON offers various benefits focused on well-being and work-life balance, including:

• Annual leave entitlements
• Health insurance options
• Retirement planning options
• Global Employee Assistance Programme with TELUS Health
• Life assurance
• Flexible country-specific benefits such as childcare vouchers, bike schemes, gym discounts, travel passes, and health assessments

Visit our careers website to learn more about working at ICON: https://careers.iconplc.com/benefits

At ICON, inclusion and belonging are core to our culture. We are committed to providing an inclusive, accessible environment for all candidates. We offer equal employment opportunities and reasonable accommodations for applicants with disabilities. For accommodations, please contact us through the provided form: https://careers.iconplc.com/reasonable-accommodations

We encourage you to apply even if you don’t meet all the requirements; you may still be a great fit for this or other roles at ICON.