Principal Clinical Research Specialist

JOB TYPE: Full Time, Employee JOB CATEGORY: Biotech/R&D/Science CITY: Spring Lake Park STATE: MNAbout Medtronic Benefits and Total Rewards It's challenging. It's energizing. It's rewarding. That's why our nearly 38,000 employees have chosen to spend their careers at Medtronic, a global leader in medical technology, providing lifelong solutions for people with chronic disease. Today, every 5 seconds the life of someone somewhere in the world is improved by a Medtronic product or therapy. Join us in our mission to alleviate pain, restore health and extend life, and discover why FORTUNE magazine named us one of the "100 Best Companies to Work For" eight of the last 10 years. Principal Clinical Research Specialist Req. # 62975Position Description Incumbent has strategic and resource management responsibility for assigned clinical programs/studies to evaluate performance, safety and efficacy of major, new products and/or modifications to existing products.  Accountable for resource prioritization, successful and timely completion of studies, coordination of activities with clinical affiliates in worldwide studies, in conformance with applicable federal regulatory requirements where appropriate.  This work is accomplished with minimal supervision. Position Responsibilities Assures successful implementation of assigned studies consistent with Research & Development program plans. Matrix development for study management activities and interface with representatives from key function groups including Product Development, Manufacturing, Sales, Marketing, Distribution, Regulatory Affairs, US Group and the European Clinical Group. Review and track study schedules and objectives as part of overall Clinical Management Plans. Assure appropriate selection and training of clinical investigators.  Coordinate activities to qualify the selection clinical study sites.  Oversee the development of study designs and investigational protocols including review of applicable reviews (investigator, institutions/hospitals, FDA/other regulatory agencies).  Oversee group compliance for control device distribution and allocation as well as clinical device forecasting.  Interface with FDA reviewers regarding requirements and results of clinical studies.  Review prepared Investigational Plan for investigator, institutions and regulatory body submission.  Assure coordination and monitoring of the activities of participating medical personnel to maintain compliance to applicable federal regulations governing the conduct of clinical studies.  Assure evaluation of data/information, providing interim reports, maintain study center communication, render clinical judgments and prepare a final Clinical Report.  Provide input to business planning process for assigned project(s) and administering budgetary expenditures.  Provide resource support, as requested, for development of initial marketing materials to support product launch activities. Publish clinical study results in medical literature and/or present at scientific meetings. Basic Qualifications KNOWLEDGE/EDUCATION Bachelor’s degree in Electrical/Biomedical Engineering, Physical/Biological Sciences, or related medical/scientific field. JOB EXPERIENCE Eight years of experience directly supporting clinical research in a project team environment or similar experience in a medical/scientific area.  5 or more years experience directly managing clinical research studies and study teams.  (Master’s Degree will substitute for one year of experience.  Ph.D. or M.D. will substitute for two years of experience.) SKILLS/COMPETENCIES Demonstrated expertise in technical area.  Strong oral/ ritten communication skills. Clinical studies technical expertise. Project management skills.  Problem solving skills. Ability to work effectively as part of multi-disciplinary teams. Ability to work effectively with the medical community. Understanding of the regulatory and compliance guidelines relevant to conducting clinical trials. Desired/Preferred Qualifications Master’s Degree.  Advanced coursework in scientific/medical/biomedical areas. Medical expertise and experience in cardiovascular disease.  Experience in working with implantable devices at all stages (concept through manufactured product). Experience with medical device regulations. Experience as a leader of multi-disciplinary group efforts. Physical Job Requirements Sitting/standing 8 + hours per day. Must be able to travel unassisted, physically type data into a computer keyboard, interact verbally on the phone and make verbal presentations.   To Apply: Click Apply Now to route your resume directly to the hiring department. No agencies or phone calls, Please Medtronic is an equal opportunity employer committed to cultural diversity in the workforce. www.medtronic.com/careers   Click here to see other Medtronic opportunities  Email this Job to a Friend