Clinical Quality Compliance Lead

Title – Clinical Quality and Training Manager Sub-Saharan Africa region (South Africa Based)

Location – South Africa

Sponsor dedicated

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.

Key responsibilities:

Identify and share the 'Clinical protocol quality' focus areas and targets to country level:

• Give quality input to the strategic plan based on upcoming clinical trial activities and Quality Management Review(QMR)
• Identify potential critical areas of the quality non-compliance and introduce preventative actions
• Prepare and execute the clinical protocol quality plan based on QMR results and issues identified in previous year(s)
• Extract quality metrics and share them with appropriate stakeholders
• Train appropriate parties in regulations and requirements to achieve audit/ inspection readiness

Manage the risk, escalate issues and provide guidance to the clinical team:

• Perform quality visits and checks to verify the clinical protocol quality status and provide feedback
• Identify issues based on data and trend analysis, inform the appropriate stakeholders about them, impose the solutions, check the implementation of the solution, escalate the issues to higher level management, if necessary
• Identify improvement areas and deliver quality protocol training to achieve the high level of quality in trial conduct
• Explain issues, answer quality questions (GCP) and provide training to all stakeholders
• Review/develop CAPA during audits/inspections

Create an environment to achieve the clinical quality objectives:

• Adopt innovative approaches in planning and conduct state-of-art trainings to all stakeholders involved in the clinical trial conduct process
• Coach internal and external (PI, other relevant site staff) stakeholders by providing focus trainings
• Act as a GCP and SOP expert and provide clarifications to all questions raised
• Provide targets on clinical quality compliance metrics
• Verify compliance with targets

Key Stakeholders:

• • Clinical Research Associates, Clinical Trial Administrators, Clinical Research Managers, Investigators and relevant site staff
  • Regional CQM, RDQ, Internal/External auditors
  • Trial Managers, other CQTMs
  • TM and CTA Managers

Experience Required:  

• 6-8 years of experience as a CRA with increased responsibility.
• Minimum 2 years of experience as a clinical research / project manager working in the pharmaceutical industry.
• In-depth understanding of clinical quality with experience in implementing clinical quality management plans across sites.
• Prior experience or willingness to work in Sub-Saharan Africa (SSA).
• Relevant Sciences Degree                                        

Skill Set

• Strategic mind-set
• Analytical skills
• Planning and execution skills
• Ability to lead without authority
• Excellent negotiation, communication & presentation skills
• Team oriented personality with high degree of flexibility - to ensure successful trial deliverables
• Ability to share knowledge and train other and proven successes
• Ability and willingness to adjust quickly to new situations in a continuously developing environment
• Proven decision making and problem-solving capabilities
• Ability to go beyond current responsibilities
• Ability to manage multiple priorities
• High focus on delivery and quality
• Ability to build and maintain strong working relationships with internal and external stakeholders
• High degree of trustworthiness

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
• 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 assuranceVisit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsICON, including subsidiaries, is an equal opportunity and inclusive employer and 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 or submit a request here.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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