Category
Regulatory, Quality and Clinical
Description
Experience Preferred:
- Science education within a STEM field (medical / healthcare focus desirable)
- Training or advanced degree in clinical research discipline
- Managing study and departmental budgets
- Knowledge and/or training in application of digital health solutions
- Leading and supporting identifying and securing funding for a range of validation studies
- Confirmable success in conducting clinical research (both small and large trials, experiential and registration)
- Involvement with medical device and/or pharmaceutical and/or digital health registry trials.
Skills:
- Business communication skills (public speaking and writing)
- Flexible with well-developed critical thinking skills
- Must be comfortable in fast paced, agile environment
- Understanding of technical medical terminology
- Strong methodological and statistical skills
- Comfortable and credible in public speaking with ability to clearly present scientific and clinical data to clinicians, sponsors, and partners
Responsibilities:
- On site management of clinical research teams, focusing on driving clinical trials to rapid enrollment and timely completion.
- Team responsibilities include:
- Drafting clinical trial protocols, reports, and submissions for publication
- Determination of study costs and timing
- Preparation of trial-related paperwork
- Coordination of sample evaluation with third-party laboratories
- Data collection and coordination
- Coordination of test material delivery to investigation sites
- Reporting of study progress to management
- Preparation of advertising for recruitment
- Monitoring of enrollment status
- Data management and adverse event reporting
- Creation and monitoring of study timelines
- Coach, manage and support research staff
- Adherence to the HITLAB processes, standards quality management system
Etc.
- Work closely with other HITLAB senior leaders on-site for business development including planning and forming external, sponsor-facing clinical educational / marketing material, such as publications, conference presentations, symposia, development of scientific advisory boards, etc.
- Developing and maintaining relationships with clinical thought-leaders in relevant fields of life sciences, digital health fields and major technology companies with healthcare ambitions
- Oversees all aspects of HITLAB clinical development processes, including establishing appropriate frameworks, tools, SOPs, training materials, etc. for fully