Seeking a key contributor to build and manage an integrated clinical development plan in global health technology. This is a unique opportunity to join a rapidly growing cutting-edge consumer and clinical medical device company that aims to transform the healthcare industry by leveraging the latest advances in artificial intelligence to advance biomarker identification and therapeutic interventions focused on sleep and electroencephalography.
- Design, oversee, and/or execute virtual and site-based clinical studies and programs ensuring timely delivery of clinical deliverables
- Support implementation teams by providing subject matter expertise, clinical science support and functional representation
- Participate in the evaluation of new project opportunities leveraging Company's unique technologies and data insights
- Responsible of key clinical documents (e.g. clinical protocols, investigator brochures (IB), clinical study reports (CSR), ICF, and other regulatory documents)
- Review, analyze, interpret, and present clinical data both internally and externally.
- Write and/or review collaborative abstracts, posters, and content for scientific meetings, conferences, and publications
- Present at investigator meetings, advisory boards and scientific conferences
- Responsible for understanding and implementing the regulatory requirements related to the clinical studies and medical device development and accountable for complying with those requirements. May be asked to contribute to regulatory responses and discussions.