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The Medical Affairs team collaborates with the leaders of Sleep, Respiratory Care, SaaS, ResMed Healthcare, and Asia Growth Markets to ensure our work, especially our clinical research and market access projects, align with their strategic priorities. We also review key government policies, as part of the continuous evaluation and improvement process that helps us maintain global compliance across an ever-shifting landscape of legal and regulatory requirements. The two, research and compliance, work hand-in-hand, and when balanced properly allow us to generate important clinical, economic and market evidence, that improves the lives of patients in ways that are scientifically valid, clinically relevant and ethically sound.
Job Responsibility:
Participates in the set-up and implementation of clinical studies through communication between the CDS and the study site.
Supports the CDS to ensure that all required devices and materials for the study are prepared and available
Ensures the clinical study database and Case Report Forms (CRFs) are prepared in advance of the study commencing
Assist in monitoring of the clinical study data during the conduct of the study to ensure compliance to the study protocol and applicable Work Instructions
Assists in audits and Regulatory Inspections as required
Verifies study documentation files and finalises the study closure reports at the completion of the clinical study
Appropriately documents and archives study data and documentation as per Work Instructions following the completion of the clinical study
Requirements:
Bachelor’s degree in relevant studies
Ability to support multiple clinical studies on relatively tight timelines and prioritise multiple tasks
Developing and maintaining relationships with internal and external stakeholders
Follows standard practices and procedures and applies basic theories, concepts, principles and methodologies in analyzing situations or data
Receives instruction, guidance and direction from others.
Proficient in software applications such as Outlook, Word, Excel and PowerPoint
Nice to have:
Previous experience in the conduct of clinical studies
Knowledge of Good Clinical Practice (GCP), ISO 14155, and other guidelines and Standards as appropriate