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 maximize 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 specialized 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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