- Minimum BA/BS in life sciences or equivalent, Masters preferred.
- 5-10 years’ experience in the medical device industry, including CRO and contract vendor management.
- 3-5 years’ experience in IDE study design, execution, and reporting. Neuromodulation therapy is preferred.
- Experience in supporting active implantable device implant and follow up procedures preferred.
- Strong planning, organizational, analytical skills, oral and written communication, problem solving, and attention to detail.
- Excellent written and verbal communication skills and strong interpersonal skills necessary to interface with physicians, outside vendors, consultants, and team members.
- Provides oversight and project management of clinical studies, including planning, execution, and completion of clinical trials according to all applicable regulations and guidance; FDA CFR Part 812, ICH/GCP, and SOPs.
- Manage development and completion of clinical study documents including authoring clinical study reports to ensure study objectives/timelines are accomplished.
- Provide oversight and clear line of communications with vendors and CROs and sites and ensure compliance to study protocols.
- Provide technical support during device implant procedures and device programming follow up.
- Supervise clinical team to ensure all clinical study activities are completed in accordance with applicable regulations and guidance; FDA CFR Part 812, ICH GCP.
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