Manager, Clinical Quality Compliance

Job Title: Manager, Clinical Quality Compliance

Job Location: United States

Job Location Type: On-site

Job Contract Type: Permanent

Job Seniority Level: Mid-Senior level

As a Manager, Clinical Quality Compliance you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• Perform and lead audits including but not limited to: clinical investigator sites, internal GCP systems/processes, external vendors, and clinical trial documents.
• Identify and report systematic issues and areas for improvement with the assistance of management/senior auditor, as needed.
• Independently perform audits, including audit preparation, conduct, presentation and timely reporting of audit findings and evaluation of CAPA Plans.
• Ensure appropriate corrective and preventative actions have been committed to by auditees.
• Conduct post-audit meetings to present/discuss audit findings.
• Assist in assessment of appropriate CAPA implementation.
• Perform other tasks as assigned by line manager.
• Contribute in the continuing development of a quality culture
• Approximately 50% travel

You are:

• BS/BA, or MS and a minimum of 5 or 10 years experience, respectively, in Biotech, Pharma, Medical Device, or Clinical Research Organization.
• Working knowledge of Good Clinical Practice (GCP) required

• Working knowledge of relevant Good Clinical Practices (GCP) and applicable regulations/guidelines. (e.g. ICH E6, 21 CFR Parts 50, 54, 56, and 312).
• Experience working with CROs, vendors, and relationship management preferred.
• Prior experience managing individuals preferred.
• Vaccine clinical trials experience is a plus.
• Excellent auditing skills and ability to communicate significant observations to Auditees in a sound and factual manner. 
• Ability to manage multiple projects in a fast-paced environment. 
• Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
• Ability to work independently and within a team environment.
• Strong communication and presentation skills, verbal and written.
• Ability to influence and negotiate effective solutions.
• GCLP experience
• Strong interpersonal skills and ability to provide training and mentoring to auditor trainees and junior staff.
• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

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.

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