Health Decisions is a full-service Contract Research Organization
(CRO) setting new standards of efficiency in drug development.
We specialize in agile clinical development using technology to
consistently slash drug development lifecycles.
Our proven approach means a
faster, more efficient solution for biotechs, pharmaceutical, and medical
device companies.
For
nearly two decades, we’ve developed and performed research in a manner that
consistently advances industry standards. Due to our strong growth plans, we
have an opening for a Device Consultant.
Responsibilities:
- Provides
consultative support for device trial proposals for project bids.
- Provides
clinical input and reviews proposal responses to ensure that projects can
be managed with contractually agreed upon schedules and budgets.
- Develop
protocol risk management plan and streamline strategies for implementation
- Contribute
to clinical protocol development via participation in protocol design
meetings to ensure operational and scientific consequences are factored
into study design decisions
- Participate
in client presentations or bid defense meetings, as needed
Liaise with the FDA and sponsor regarding
trial design
Requirements:
- Undergraduate degree in sciences, clinical, or health related
field from an accredited university
required
- Class
II/III medical device experience in clinical development specifically with
the development of study protocols
- Working
knowledge of FDA regulatory requirements for medical device trials
- Proven experience in trial management, protocol
development and implementation for device trials
Excellent verbal, presentation, and written skills
·
Health Decisions is an equal opportunity
employer.
Interested candidates should submit their resume to careers@healthdec.com
