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
- 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
- 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
- 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
- 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
- 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
Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best-in-class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
Our success depends on the knowledge, capabilities and quality of our people. Thats why we are committed to developing our employees in a continuous learning culture one where we challenge you with engaging work and where every experience adds to your professional development.
ICON, 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.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless theres every chance youre exactly what were looking for here at ICON whether it is for this or other roles.
