Clinical Quality Compliance Specialist

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

What you will be doing:

The CCQM will oversee all Clinical Quality Management (CQM) related activities in Sub-Saharan Africa. The CCQM will work in close collaboration with the Clinical Research Directors (CRD) and the local clinical operations team. In addition, the CCQM will support CQM activities at the regional and/or global level as needed and upon the request of the RCQM NA. This includes to participate/take the lead in regional/global process improvement initiatives.

Specific responsibilities include:
Audits & Inspections: The CCQM will be the primary point of contact for Global Compliance and
Regulatory Agencies, manage and support activities during the preparation and ongoing phase of
an audit/inspection. In cooperation with the local team and/or headquarters, the CCQM will
perform a root-cause-analysis for audit observations/inspection findings, manage and track the
Corrective and Preventive Actions (CAPAs) as well as coordinate and facilitate the responses to
audit/inspection reports. On a regular basis and in collaboration with the local team as well as the
RCQM NA, the CCQM will look into local trends, perform a root-cause-analysis (if necessary) and
develop a local action plan

Processes & Regulations: The CCQM will be the local expert for ICH-GCP and local regulations.
In close collaboration with the CRD, the CCQM will manage the local SOP/SME network to
ensure a proper implementation of global/local procedures and the regular update of local SOPs.
The CCQM will also identify process improvement opportunities and/or process gaps and
properly escalate to the RCQM NA and/or headquarters (if necessary).

Training: The CCQM will be the local training point of contact and the liaison between local GCTO
and Learning & Development. In close cooperation with the CRD, the CCQM will identify local
training needs and initiate local training activities.

Quality Control (QC) Activities: The CCQM will ensure the proper execution of the In-house
Quality Control Plan (IHQCP) as well as the Quality Control Visits (QCVs). . Upon request and in
mutual agreement with the CRD and the RCQM NA, the CCQM may also perform QC activities
and site visits. On a regular basis and in collaboration with the local team as well as the RCQM
NA, the CCQM will look into local trends, perform a root-cause-analysis (if necessary) and
develop a local action plan.

Vendor Qualification: The CCQM will lead local vendor qualifications of locally selected vendors
and supports solving of quality issues with locally selected vendors. Upon the request of the
RCQM NA, the CCQM will also support the Quality Management System (QMS) assessment of
global vendors.

You are:

• Bachelor's Degree or equivalent in relevant health care area.
• A minimum of 6-8 years of relevant experience in clinical research including direct field monitoring experience or management/ oversight of such individuals, with a demonstrated record of accomplishments
• Deep knowledge and understanding of Clinical Trial processes as well as quality management and control tools is required.
• Demonstrated experience leading cross-functional teams of business professionals.
• Solid track record of initiating, planning and delivery of projects and knowledge of project management practices.
• Experience in managing audits and inspections is preferred
• Experience in coordinating and delivering training sessions is preferred
• Superior oral and written communication and people management skills in an international environment.
• Excellent project management and organizational skills.
• To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status

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

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 organisation. 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 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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