Clinical Quality and Training Manager South Africa & Sub-Saharan Africa at ICON plc

About the role

As a Clinical Quality and Training Manager Sub-Saharan Africa region(South Africa Based), you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. You will be a part of ICON Strategic Solutions, embedded to a sponsor.

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.

• With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
• Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

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:    

• A minimum of 5 years of relevant experience in clinical operations/clinical trials, having been responsible for Quality Oversight of Clinical Trials.
• MBChB,PhD, or MSc degree in Pharmacology or similar is required.
• Experience in Quality Oversight of trials across Sub-Saharan Africa and South Africa
• Be prepared to travel outside of South Africa

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