Job Responsibilities
• Ensure clinical trial processes and procedures are conducted in accordance with GCP, relevant regulations, guidelines, protocol, and quality management system
• Assist with the management of QMS and related activities e.g. account management
• Document control of quality management system
• Review and update SOPs, forms, and templates
• Assist in internal process audits, study specific audits, site audits and preparation of audit reports
• Assist in CAPA management, root cause analysis and provide suitable recommendations for improvements
• Assist in the conduct of quality management review meetings
• Keep up to date with regulatory guidelines and legislations and utilize relevant documents to interpret for guidance
• Assist in vendor selection audit procedures and vendor oversight assessment reviews
• Review of essential documents for clinical trials and documents for regulatory submission
• Management of QMS and study related trainings
• Assist with risk management/ assessments
• Perform other related duties as assigned
Skills and Qualification
· A bachelor’s degree in a science related
· A minimum of 1 years’ experience in a clinical research (GCP) role
· Strong analytical and critical thinking skills
· Ability to exercise good judgement under pressure and tight deadlines
· Strong communication and inter-personal skills
· Flexible in adapting to variety of responsibilities and work assignments.
