Clinical Project Manager

Mô tả công việc

Clinical Project Manager Muffin Incorporated is currently accepting applications for a Clinical Project Manager. This position is responsible for organizing and conducting clinical studies.   Responsibilities Provide technical and scientific support/guidance in the development, initiation and conduct of clinical studies; Develop and maintain a working knowledge of FDA and other global regulatory requirements that may impact global clinical studies including ICH GCP, JGCP and ISO 14155; Provide leadership in the development and review of study-related documents; Establish and maintain close working relationships with physicians, outside consultants and other study personnel through exceptional communication on a regular basis; Responsible for achieving study objectives by working with team members to set project priorities and milestones and resolve project conflicts; Track study metrics (progress) in order to manage investigative site and study team resources toward achievement of milestones; and Participate in the analysis, summarization and reporting of clinical data for regulatory or marketing purpose throughout the course of the study. Essential Qualifications Master’s degree in Health, Life Sciences or Biomedical Engineering, preferred. A Bachelor’s degree with significant relevant experience is required. Previous experience in the conduct of clinical studies preferred, preferably in the medical device industry; Proven ability to exercise sound judgment in independent decision making; Conscientious, influential person with an outstanding work ethic and strong personal discipline; Ability to interact with physicians, scientists and company executives in a professional and personable demeanor in a variety of settings and interactions Willingness and capability to handle multiple projects and responsibilities; Excellent organizational, leadership and problem-solving skills; Excellent written and verbal communication skills. Ability and desire to work in a collegial team atmosphere; including communicating and working constructively with colleagues. Sufficiently assertive to deal with confrontational situations. Experience in writing technical documents. Willingness and ability to travel 25-50% of the time.