Sr Clinical Research Spec Job
Job Code - 81987
Position - Full Time - Regular
Job First Active on: Thursday, April 12, 2012
Sr Clinical Research Spec
Study management responsibility for assigned clinical programs to evaluate performance, safety and efficacy of major, new products and/or modifications to existing products. Accountable for successful and timely completion of these studies, often of worldwide scope, in conformance with applicable federal regulatory requirements. This work is accomplished with minimal supervision.
• Assures successful conduct of assigned studies consistent with Research & Development program plans.
• Matrix management and interface with representatives from key functional groups including Product Development, Manufacturing, Sales, Marketing, Distribution, Regulatory Affairs, and the European Clinical Group.
• Determine study schedule and objectives as part of overall Clinical Management Plan.
• Select and train clinical investigators. Coordinate the clinical study activities of these investigators.
• Develop the study design and investigational protocol including preparation of applicable reviews (investigator, institutions/hospitals, FDA/other regulatory agencies).
• Control device distribution and allocation as well as clinical device forecasting.
• Interface with FDA reviewers regarding requirements and results of clinical studies.
• Prepare Investigational Plan for investigator, institutions and regulatory body review.
• Coordinate and monitor the activities of participating medical personnel to maintain compliance to applicable federal regulations governing the conduct of clinical studies.
• Evaluate 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 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.
• Bachelor’s degree
• At least 4 years of experience as a Study Manager. (Master’s Degree will substitute for one year of experience. Ph.D. or M.D. will substitute for two years of experience.)
Physical Job Requirements
REQUIREMENTS - QUALIFICATIONS: Sr Clinical Research Spec
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