Regulatory & Compliance Manager - Johannesburg Verfied

Salary Negotiable Johannesburg, Gauteng Johannesburg, Gauteng more than 14 days ago 09-09-2021 4:10:56 PM
Minimum Required Qualifications and Experience:
? Grade 12
? 3-year diploma or degree in a health-related field.
? A post graduate degree in Quality Management would be an added advantage. Understanding of the research language, detailed knowledge and understanding of the relevant studies and SOP’s, knowledge of clinical research documentation. Detailed knowledge of regulatory application and approval processes


TECHNICAL AND BEHAVIOURAL COMPETENCIES
? Confidence & Self Control
? Ethics and Integrity
? Initiative
? Planning and Organising
? Professionalism
KEY PERFORMANCE AREAS
? Technical Support
? Create, establish and maintain regulatory systems for WRHI studies per MCC, WHREC, sponsor and DOH requirements
? Provide expert guidance on the requirements of local and international regulatory bodies and frameworks, and support the department to comply with those requirements
? Monitoring including QA/QC
? Ensure participants are enrolled per defined eligibility criteria
? Review and improve systems to monitor compliance with GCP and recommend interventions to identify, evaluate and rectify problems in Case Report Review and advise on improvements and standardisation of quality control and assurance systems with respect to improved compliance with regulatory frameworks
? Provide training to staff and students in areas of expertise to reduce repetitive errors noted during study file review
? Forms (CRF) and study specific document completion
? Effective self-management and performance ownership
? Take ownership and accountability for tasks and demonstrate effective self management.
? Follow through to ensure that quality and productivity standards of own work are consistently and accurately maintained




Recruiter: Right to Care