Global Clinical Project Lead

2 days ago

Cork, Cork, Ireland beBeeClinicalProjectManagement Full time €90,000 - €110,000
Job Title: Clinical Project Manager

As a Clinical Project Manager, you will lead cross-functional study teams in the development and execution of clinical trials. Your responsibilities will include developing and executing local, regional, and global clinical trials, partnering with organizations to coordinate affiliate, site, and investigator training, and driving and coordinating cross-functional study teams throughout study implementation, execution, and closure.

You will be accountable for trial/regional enrolment strategy and execution, manage relationships and serve as a single point of contact for trial communication, and apply problem-solving skills to daily issues with cross-functional study teams.

  • Develop and execute local, regional, and/or global clinical trials using project management skills, processes, and tools.
  • Partner with organizations to coordinate and actively participate in affiliate, site, and investigator training.
  • Drive and coordinate local, regional, and global cross-functional study teams throughout study implementation, execution, and closure.
  • Be accountable for trial/regional enrolment strategy and execution starting from country allocation through Last Patient Entered Treatment (LPET).
  • Manage relationships and serve as a single point of contact and central owner for trial communication to and from the Clinical Development team.
  • Apply problem-solving skills to daily issues with cross-functional study teams.
  • Identify and assist in developing continuous improvement activities based on important trends such as industry, regulatory, new technology, etc.
  • Manage Third Party Organization qualification process, selection, and oversight.
  • Accountable for ensuring a state of inspection readiness of the TMF records created, maintained, finalized, and owned by the Clinical Development team.
  • Apply expertise and knowledge of global/regional regulations & Good Clinical Practice (GCP) and leverage scientific and regulatory knowledge to prepare and/or provide technical consultation for clinical and regulatory documents, prepare for meetings with regulatory agencies, and draft responses to questions from regulatory agencies, Third Party Organizations, and affiliates.
  • Combine scientific, regional, and operational knowledge as well as process expertise to impact clinical trial design, feasibility, and implementation.
  • Utilize clinical development knowledge, problem-solving, and critical thinking skills to support the scientific needs of the business.

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