Medtronic is an Equal Opportunity/Affirmative Action Employer
As a global leader in medical technology with 45,000 employees around the world, Medtronic is redefining how technology is used in the management of chronic disease. We're committed to Innovating for life by pushing the boundaries of medical technology and changing the way the world treats chronic disease. We pride ourselves in living our mission to alleviate pain, restore health, and extend life. Today our mission is more relevant than ever, as we work across borders, across disciplines, and across industries to deliver new and innovative medical technology solutions that help improve healthcare around the world. Currently we improve the life of one person every 4 seconds, with a goal to deliver life enhancing technology to one person every 1 second by 2020.
As part of the Cardiac and Vascular Group, Endovascular Therapies is fastest growing business at Medtronic (revenue growth of 20% in FY 2011). Our division develops innovative treatments for thoracic and abdominal aortic, peripheral vascular, and carotid artery diseases. Our vision is “To ensure that all patients at risk for vascular disease receive proper education, detection and an endovascular treatment.”
We positively impact a life of a patient every 3 minutes.
Endovascular Clinical Affairs is looking for passionate, motivated, strategic thinker to support a global clinical trial in a dynamic environment. This position is responsible for supporting the generation of high quality clinical evidence as a study team member for their assigned clinical program(s) to evaluate the safety and effectiveness of the product(s). As part of this, the candidate is accountable for managing clinical study sites, ensuring quality data, and maintaining study compliance with clinical affiliates for worldwide studies in conformance with applicable federal regulatory requirements.
We are looking for a candidate with growth potential, strong customer relationship focus, the ability to influence others, and the ability to become a therapy expert (peripheral and/or aortic).
• Accountable for meeting the milestones of a clinical study in compliance with applicable clinical and regulatory standards
• Accountable for direct site management, for site activation, and patient tracking
• Has complete understanding of subject data and study trends
• Ensures quality data reporting at the sites
• Establish effective relationships with study sites
• Executes site staff training to ensure compliance to the Investigational Plan and regulations
• Facilitates the accurate reporting of AEs for CEC adjudication, Field Assurance, and regulatory reporting
• Effectively communicate study status to management on a regular basis
• Provides management with site specific activities for reporting and evaluation
• Highly proficient in DOP/SOP application in the clinical trial
• Support the clinical core team in coordinating study activities, such as collecting, reconciling, and reporting clinical data for the study
• Ability to lead a trial under supervision
• Thirst to learn and grow
• Innovative - not afraid to think “outside the box”
• Customer focused
• Takes ownership and self-motivated
• Works effectively on cross-functional teams
• Results and solution oriented
• Strong project management skills
• Good understanding of clinical trial subject matter
• Good understanding of biostatistics and trial design
• Good understand the therapy or ability to learn quickly
• Strong written, oral, and interpersonal communication skills including proficient knowledge of medical terminology
• High attention to detail and accuracy
• Good prioritization and organizational skills
• Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), and ISO 13485:2003 and 14155:2011
• Strong knowledge of World Health Organization (WHO) Good Clinical Practice (GCP) and International Conference on Harmonization (ICH)
• Proficient in MS Office products, word processing, spreadsheets, etc.
• Doctorate degree in Life Science/Engineering/Public Health
• Bachelor/Master degree in Life Sciences/Engineering/Public Health/Business
• Masters degree will substitute for 1 year of experience. Doctorate will substitute for 2 years of experience.
• 1-3 years of clinical research experience in medical/scientific area