Provide strategic Quality oversight on the entire Clinical Trial Process for the clinical trials under responsibility in order to ensure compliance with the Health Authorities requirements, the internal standards and full adherence to patients’ safety, rights and well-being.
Based on risk analysis, take critical decisions together with internal stakeholders, ensuring clinical trials have no delays whilst maintaining high-quality level data.
Takes full ownership of the quality aspects of the assigned clinical trials.
- Proactively provide QA leadership to the business strategy for assigned trials by ensuring considerable organization awareness (e.g. Interrelationship of departments and business priorities)
- Support implementation of quality strategy within GCT under the responsibility
- Regularly monitor the implementation of the annual Quality Plan pertaining to the Clinical chapter and ensure that all delayed activities have a documented rational and appropriate escalation
- Ensure adequate oversight of proactive quality risk management process in the overseen areas including quality risk assessments and submission/inspection readiness activities and ensure that CTP processes are in control
- Provide robust and clear quality oversight for clinical development
- Actively leverage audit/inspection outcomes/trends to sustain improvement in clinical trials conduct.
- Degree in Life Sciences, Pharmacy or Medicines. Advanced degree a plus
- +7 years of involvement in regulated activities (GCP/PV), clinical development and/or QA positions
- Broad understanding of global expectations of Health Authorities in the area of Clinical Development and profound understanding of the science of product development
- 3 or more years’ experience in managing projects
- Ability to effectively interact with and present to senior management at all levels, as well as to external audiences and inspectors
- Strong skills in GCP, quality and/or clinical development
- Strong interpersonal, communication, negotiation, and problem-solving skills
- Fluency in English (oral and written)