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 Clinical Operations Manager.
What you will be doing:
- Effectively oversee CRAs and/or CTAs in the Southeast Region for one of our FSP programs, ensuring high performance, quality, and continuous development.
- Interview, evaluate, and select CTAs and CRAs.
- Assist in fulfilling site management activities for clinical studies.
- Serve as the point of contact for Clinical Trial Operation Managers.
- Manage key activities during CRA/CTA absence.
- Conduct CRA accompanied visits and quality oversight activities.
- Interact with KOLs, investigators, and site staff for clinical trials execution.
- Ensure compliance with SOPs, policies, regulations, and guidelines.
- Support FSP staff in achieving study objectives and resolving site issues.
- Ensure CRAs and CTAs are qualified, trained, and meet quality requirements.
- Provide leadership for continuous improvement in performance and monitoring processes.
- Develop action plans and resolve findings from Clinical Quality Assurance audits.
- Conduct resource planning, metrics review, and performance assessments.
- Update Senior Management and adhere to metrics.
- Review and approve itineraries, expense reports, and visit reports.
- Supervise IRB/IEC and Regulatory Authority Submission processes if applicable.
You are:
- BA/BS/BSc or qualified nurse (RN)
- At least 2 years experience in life sciences or medically related field, including biopharmaceutical clinical research experience
- Strong understanding of FDA regulations, ICH guidelines, and GCP standards
- Proficiency with clinical trial management software and tools
- Excellent verbal and written communication skills
- Proven leadership and team management abilities
- Ability to adapt to changing priorities and work in a fast-paced environment
- Ability to maintain strong relationships with clients and stakeholders
- Experience in monitoring and improving team performance
- High level of attention to detail and organizational skills
- Must be able to travel to various locations throughout the southeastern United States
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, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organization. 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 through this form.
