Clinical Project Manager

Our client develops cutting edge artificial intelligence systems that are transforming the way cancer is diagnosed. This technology enables rapid and accurate decision-making, and illuminates new diagnostic insights to enable precision medicine.

Responsibilities:

  • Manage US clinical trials and research across all aspects of clinical/research sites, including protocols and support for regulatory documentation

  • Travel to clinical sites in North America

  • Oversee and supervise clinical operations and vendors/CROs to ensure that these activities are conducted in accordance with applicable regulatory requirements and guidelines (including company SOPs, ICH-GCP guidelines, regulatory authority regulations, and patient safety standards)

  • Identify and recruit appropriate clinical sites and  investigators 

  • Maintain strong relationships with external experts and Investigators to ensure effective execution of clinical projects

  • Develop and write clinical study protocols and plans, IRB submission documents, CRFs, and clinical study reports

  • Facilitates training for clinical study teams 

  • Ensure the generation of high-quality data

  • Collaborate cross-functionally to ensure successful, rigorous, and timely studies

  • Analyze, interpret, and present results to internal and external stakeholders 

 Requirements:

  • Master’s degree in life sciences, biomedical engineering, or other related discipline 

    • PhD or MD preferred

  • GCP/CRA certified

  • 4+ years’ experience managing clinical development activities in medical device industry 

  • 2+ years’ experience in Clinical Affairs

  • Proven knowledge of medical device, IVD clinical development, and oncology

  • Experience and familiarity with FDA and other applicable regulatory guidelines and documents

  • Prior experience in clinical development planning, study design, biostatistics, monitoring, data handling, data analysis, and report writing

  • Proven ability to independently lead peers in completion of complex plans

  • In-depth understanding and experience across the clinical operations value chain, with a track record of success in study planning, execution, data management, study reporting