Clinical Research Lead Digital Health

  • Anywhere

Company :

Location :
San Diego, California

Expiry Date :
Fri, 05 Feb 2021 23:59:59 GMT

Apply Job :
Open Link

Description :
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. Let’s_Talk_About_The_Team_And_You As a Digital Health Clinical Specialist, you will be responsible for capturing and organizing key information from business stakeholders, determining clinical requirements, plan and execute studies. You will be required to maintain a deep knowledge of processes and clinical science and apply this knowledge to the development of new products and manage the planning, development and implementation of clinical research across the business. We are looking for someone who is flexible and can respond quickly, energetically, and enthusiastically to changes. Cross-functional communication skills and experience are essential. The Digital Health Clinical Specialist will interact with engineering disciplines, data analysis, legal, business development, and other project management teams. Having exposure and familiarity with the changing dynamics of research and development in the digital realm is highly desired. Let s_Talk_About_Responsibilities * Work closely with all client groups (Product Management, Product Development, Marketing, Quality, Regulatory, Research Groups, NBC) to support business activities by providing clinical expertise and support * Stay abreast of new research in areas of interest, educate key stakeholders and determine ways to test and/or incorporate into the ResMed ecosystem if appropriate * Be thoroughly informed of all ResMed digital offerings (eg myAir, AirView) and run feasibility studies, clinical studies and/or data integration projects using these or similar platforms. * Work with external digital health companies and run pilot projects to determine their efficacy and appropriateness in the ResMed ecosystem * Create new processes if appropriate for digital studies in collaboration with all stakeholders * To provide clinical input into global product development across all business units to ensure the safety, efficacy, and usability of ResMed products. * Research, make recommendations, project manage and conduct clinical trials, clinical studies, and usability evaluations. * Liaise with client groups (Product Development, Product Management, Marketing, Quality Assurance, Regulatory, Research Groups, NBC) to provide clinical support. * Develop and draft clinical trial protocols, ethics documents, and trial reports, support team members with clinical study design. * Acting as review lead on Medical Affairs deliverables where agreed by Medical Affairs management. * Provide clinical input to support the ongoing life of existing products (ie. risk assessments, field complaints, marketing material). * Develop white papers, conference posters, journal papers, and other scientific literature. * Develop training materials and facilitate specialized clinical and medical educational sessions for the business. * Lead improvements to Medical Affairs processes ensuring that new processes or process improvements are compliant with regulations Let s_Talk_About_Qualifications_And_Experience * Experience running clinical trials * Experience with data analysis * Strong human research background with clear understanding of study lifecycle * Experience with using digital platforms to run end-to-end clinical studies * Demonstrated ability to liaise with key stakeholders in the medical/ scientific world * Advanced analytical and excellent communications skills * Highly organized and hyper-attentive to detail * Thrive in a fast-paced environment * Ability to adapt, improve, and champion best practices * Self-motivated and proactive with the critical thinking and resourcefulness to achieve study objectives * Working knowledge of US, EU, APAC, LATAM, ASEAN and other global regulations, standards, and guidance Desirable * Experience running clinical trials using apps, IoT devices and other digital platforms * Experience in medical device product development as a clinical resource. * Bachelor s Degree in Medical Science, Science, Engineering or Health Sciences Joining us is more than saying yes to making the world a healthier p It s discovering a career that s challenging, supportive and inspiring Where a culture driven by excellence helps you not only meet your goals, but also create new ones. 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! Show moreShow less