Meta Health team is looking to improve individual and public health outcomes at Meta scale by developing clinically validated health products. The Director of Health Research Operations will lead research operations for the Meta Health team to plan and execute research and validation of novel digital approaches for measuring and improving health.
Requirements
- 15+ years relevant experience in health research, including medical devices and/or digital health technologies and oversight of clinical research operations
- Experience in oversight of clinical research protocol implementation and data quality monitoring, such as in clinical trials and/or medical device development or digital health product development
- Experience in people management of clinical research operations teams for large clinical research studies
- Understanding of study design and methodology, to inform study protocol execution and oversight of data quality and research operations
- Experience collaborating with cross-functional teams
- Prior experience with wearable consumer or digital health technologies and related research studies
- Experience in regulatory studies and strong knowledge of Good Clinical Practices, FDA rules and regulations in relation to clinical trials, and ICH regulations
Responsibilities
- Partner with Clinical Research Scientist Leads in planning and execution of all Health studies.
- Oversee research operations (clinical research operations) to execute internal and external studies end to end, spanning CRO/vendors selection, site selection and qualification, study documents and manuals, IRB, study site training and monitoring protocol adherence, recruiting and participant enrollment, standard operating procedures, data collection, device monitoring and troubleshooting, manage and review all site visit reports
- Ensure the integrity, accuracy, and reliability of research data collected to develop and validate health algorithms and inform product decisions
- For all Health projects, plan, develop and implement data quality tools and as needed to validate and optimize data quality, as well as data management, data standards and electronic data capture
- Align across the Health team and relevant cross-functions on data quality metrics and tracking through regular reviews and communication with Health leadership
- Develop and strengthen resources, programs and services that facilitate clinical research operations with a continuing focus on quality improvement, cost-effectiveness and productivity enhancement
- Manage and provide accountability for day-to-day operations of the study team and according to ICH/GCP and all other applicable laws, rules, and regulations
Other
- The candidate has the experience and ability to deliver high quality work in a fast-paced, broad scope, product-minded environment.
- Serve as primary Sponsor contact for operational project-specific issues and study deliverables
- Prioritize tasks and priorities in a fast-paced environment with time-sensitive deadlines
- Prior experience in reporting to senior management and managing clinical budgets
- MD, PhD, or other relevant degrees or training
