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.
The primary role of Clinical Studies and Development is the oversight, administration, and execution of the approved clinical study plan. This will include all aspects of the execution of the study, such as contracting, documentation, site visits, and report writing. This role may be as a Study Manager, Clinical Trials Associate, or other similar role.
Let's talk about Responsibilities- The primary objective of Clinical Research (CSD) specialization within Clinical Studies & Development Job Family is to oversee and develop clinical projects including research studies in relation to product development.
- Provides strategic input and development support for clinical plans and individual study protocols.
- Participates in the development of clinical operating guides and maintains secure study files.
- Reviews results of these studies with appropriate management prior to publication.
- Demonstrates appropriate technical proficiency, scientific creativity, collaboration with others and independent thought.
- Focuses on the development and implementation of strategic and operational objectives that help achieve orgnisational mission. Implements organization strategies through the effective direction and management of employees and resources.
- Regularly interacts with executives and/or major customers.
- Interactions frequently involve special skills, such as negotiating with customers or management or attempting to influence senior level leaders regarding matters of significance to the organization.
- Provides leadership to managers, supervisors and/or professional roles.
- Leads larger number of employees, multiple sub-teams, or large teams with complex or highly technical responsibilities.
Let's talk about Qualifications and ExperienceRequired:Preferred:- Bachelor's degree.
- Minimum of 12 years of related experience.
- Looks beyond existing methodologies and own discipline to define and resolve complex problems, has in-depth knowledge of organizational objectives.
- Demonstrated versatility.
