Clinical Development Specialist – Diagnostics

Overview

Clinical Development Specialist – Diagnostics

Location : ResMed Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia

Role summary

We are seeking an enthusiastic and detail-oriented Clinical Development Specialist – Diagnostics to join our Medical Affairs team. In this role, you will play a critical part in the design, implementation, and oversight of clinical development activities that support our sleep diagnostics portfolio. You’ll work cross-functionally to ensure that our products have the correct requirements and to define and execute on strategies to generate high-quality evidence to support the safe and effective use of diagnostic solutions across various healthcare settings. This is a unique opportunity to contribute to the development of cutting-edge diagnostics that enable timely, accurate decision-making for patients and providers.

Key Responsibilities

• Support the planning and execution of clinical studies—including analytical validation, clinical validation, and usability studies—aligned with diagnostic development goals.
• Assist in developing study protocols, investigator brochures, case report forms (CRFs), and other clinical study documents.
• Collaborate with internal stakeholders such as Regulatory Affairs, Clinical Operations, R&D, and Marketing to ensure integrated study planning and execution.
• Liaise with external investigators, clinical sites, and contract research organizations (CROs) to support effective study conduct and data integrity.
• Participate in data analysis and interpretation activities to support product development, regulatory submissions, and scientific communications.
• Track study timelines, milestones, and budgets to ensure clinical projects are completed on time and within scope.
• Maintain a strong understanding of diagnostic regulatory pathways (e.g., FDA, CE-IVD, CLIA) and ensure compliance with applicable clinical and ethical guidelines.
• Contribute to the development of abstracts, posters, and manuscripts to communicate clinical evidence to external audiences.

Required Qualifications

Preferred Qualifications

Core Competencies

Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now! We commit to respond to every applicant.

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