|
WHAT
IN
Sr Clinical Research Manager Ventor
Job
Medtronic
US
-
Mounds View,
Minnesota
Job Code - 69094
Position - Full Time - Regular
Job First Active on: Monday, October 26, 2009
APPLY TO THIS JOB (You will be applying directly to Medtronic for this position!)
JOB DESCRIPTION: Sr Clinical Research Manager, Ventor
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.
REQUIREMENTS - QUALIFICATIONS: Sr Clinical Research Manager, Ventor
• 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.
• Lead a broad segment of clinical research staff to ensure clinical project deliverables are achieved.
• Create positive work environment by encouraging customer focus, mutual respect, accountability and exceptional performance at all levels.
• Bachelor’s degree in Electrical/Biomedical Engineering, Physical/Biological Sciences, or related medical/scientific field.
• Seven years of experience directly supporting clinical research in a project team environment or similar experience in a medical/scientific area. Three 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.)
• Experience leading clinical teams in matrix environment.
• Experience managing a clinical team with various levels of experience and demostrated supervisory skills.
Medtronics
Back To Results
Apply to this job!
View Company Jobs
Free Career Test
Your Resume on 75 Job Sites
|
The goal of CareerTopJobs is to help candidates find
jobs more easily, like the job listed on this page, "Sr Clinical Research Manager, Ventor, in Mounds View, Minnesota - Medtronic". We hope CareerTopJobs will become your job source for finding open job positions in the
Biotechnology and
Pharmaceutical industry job market.
