Clinical Quality Compliance Lead
- United States
- Clinical Trial Support
- ICON Strategic Solutions
- Remote
TA Business Partner
- Icon Strategic Solutions
About the role
As a Clinical Quality Compliance Lead you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What you will be doing:
- Performs proactive as well as routine evaluation of clinical trial processes to determine adherence to process and procedural documentation through documentation review and active engagement with study team functional representatives
- Helps develop and maintain KPIs, metrics and dashboards to track process quality and compliance
- Provides near real-time feedback on study process and documentation quality as well as team performance and understanding on evaluated processes.
- Ensure compliance with own Learning Curricula, corporate and/or GXP requirements.
- Represent GCP Compliance in meetings as needed.
Performs other duties as assigned.
You are:
- Minimum of 4+ years clinical research experience in pharmaceutical or biotechnology field
- Solid knowledge of drug development, clinical trial management and/or GCP compliance processes
- Proven track record of managing projects and activities related toclinical trial delivery or complliance activities for drug development programs.
- Experience in problem solving, negotiations and collaborative team building with non- direct reports and other stakeholders is required
- Solid knowledge of regulatory requirements governing clinical trial, industry best practices and related standard and documentation requirements
- BS, MS or equivalent in scientific field
- Must be able to efficiently utilize computer software programs such as Microsoft Office for general use, project management and presentations
- Effectively resolve conflict in a constructive manner
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 maximise 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 website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
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, colour, 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 through the form below.
https://careers.iconplc.com/reasonable-accommodations
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.
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Learn more about Our Culture at ICON
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