Medtronic is looking to manage the daily operations of key market adoption studies and novel data collection activities for their Endoscopy operating unit, which aims to improve patient outcomes by empowering gastroenterologists with AI and disruptive therapeutic technologies for early detection and treatment of gastrointestinal diseases and cancers.
Requirements
- Experience with GCP, GDP, and regulatory compliance guidelines for clinical trials
- Experience with Electronic Data Capture (EDC) systems
- Experience working with an IRB
- Work experience supporting clinical research or experience in a medical/scientific area
- Education in life sciences or related medical/scientific field
- Proficiency in Microsoft Office/365 including Word, Excel, PowerPoint, and Outlook
- Knowledge of medical terminology.
Responsibilities
- Oversees, designs, plans and develops clinical evaluation research studies.
- Prepares and authors protocols and patient record forms.
- Conducts registered and non-registered clinical studies of products that have been determined to satisfy a medical need and/ or offer a commercial potential.
- Oversees and interpret results of clinical investigations in preparation for new device or consumer application.
- Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations and may prepare clinical trial budgets.
- May be responsible for clinical supply operations, site and vendor selection.
- Represents Medtronic from a clinical research respective within the country / region and also collects feedback from local customers and authorities.
Other
- The candidate is preferred to be in the Lafayette, CO or Mounds View, MN, In-office.
- Travel <25%.
- Advanced written and oral communications skills
- High attention to detail and accuracy
- Capable of working on multiple projects with ability to shift priorities & work plan based on department needs
