Clinical Project Manager

Posting Date 2 weeks ago(11/12/2021 11:46 AM)
Requisition ID
2021-9864
Job Location(s)
West Lafayette IN United States
Travel
10-20%
Position Type
Full Time
Company
Med Institute Inc.
Category
Clinical

Overview

This position is responsible for coordination of clinical studies to meet regulatory and client objectives through the life-cycle of the clinical study, including a range of activities from protocol development through data analysis.

Responsibilities

 

  • Develop and maintain a working knowledge of FDA and other regulatory requirements that impact global clinical studies including ISO 14155, ICH GCP, and JGCP;
  • Responsible for achieving study objectives by working with team members to set priorities and milestones, while resolving project conflicts;
  • Understand and accept customer requests with an "I can help you" attitude;
  • Coordinate, develop and/or review all essential clinical study-related documents;
  • Establish and maintain close working relationships with clinical site personnel, electronic data capture (EDC) vendors and other clinical vendors, and client stakeholders through exceptional communication on a regular basis;
  • Responsible for database management and statistical analyses;
  • Track study metrics (progress) in order to lead investigative site and study team resources toward achievement of milestones;
  • Lead meetings with investigative sites, physicians, and vendors as needed to ensure the success of the clinical study;
  • Train the study team, including investigators, site research staff, and vendors on study requirements;
  • Lead study team meetings with both internal and external stakeholders;
  • Respond promptly and appropriately to study issues raised by investigative sites, monitors, and vendors;
  • Work closely with others to ensure that appropriate resources are available for the project's success and that they are appropriately informed in a timely manner to offer guidance in resolving issues;
  • Participate in the statistical analysis, summarization, and reporting of clinical data for regulatory or marketing purpose throughout the course of the study; and
  • Travel as needed- (once restrictions are lifted)

Qualifications

  • Bachelor’s degree with significant relevant experience is required;
  • Master’s degree in Health, Life Sciences or Biomedical Engineering is preferred;
  • Previous experience in the conduct of clinical studies is very beneficial;
  • Proven ability to exercise sound judgment in 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, listening, and verbal communication skills;
  • Ability and desire to work in a collegiate team atmosphere; including communicating and working constructively with colleagues;
  • Sufficiently assertive to deal with confrontational situations and resolve conflicts;
  • Experience in writing technical documents; and
  • Willingness and ability to travel as needed.
  • Current U.S. work authorization and proof of FDA authorized COVID19 vaccination are required for this position.
  • Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position

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