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Clinical Research Project Leader

2 months ago

Lafayette, Louisiana, United States Cook Medical Full time

Job Overview

In the role of Clinical Project Manager at Cook Medical, you will play a pivotal role in managing the execution and conclusion of clinical trials. Your responsibilities will encompass planning, analysis, and the coordination of interdisciplinary teams to ensure that studies are completed successfully and align with the strategic objectives of the organization.

Key Responsibilities

  • Acquire and maintain a comprehensive understanding of regulatory guidelines and standards that influence clinical trials.
  • Direct documentation and training initiatives for both internal teams and external partners.
  • Oversee activities related to designated studies, which include site assessments, audits, and participant recruitment.
  • Facilitate the creation of study-related documents and educational resources.
  • Ensure that studies progress in a timely manner while complying with all regulatory requirements.
  • Foster effective communication among teams and stakeholders.
  • Assist in the preparation of regulatory submissions for clinical trials.
  • Lead external meetings and preparations for studies.
  • Address critical issues by escalating them to management as necessary.
  • Guarantee the accuracy of study registration and data integrity.
  • Engage in strategies aimed at process enhancement.

Required Qualifications

  • A Bachelor's or Master's degree accompanied by relevant experience.
  • Previous experience in clinical studies related to medical devices or pharmaceuticals is preferred.
  • Excellent decision-making and communication abilities.
  • Capacity to manage multiple projects while collaborating effectively within a team.
  • Openness to travel as required.

If you possess the legal authorization to work in the United States and meet the outlined qualifications, we encourage you to consider this opportunity with Cook Medical.