Clinical Study Director

3 days ago

Cork, Cork, Ireland beBeeProject Full time €60,000 - €80,000
Clinical Project Manager Position

Clinical project managers are accountable for leading cross-functional teams in the development and execution of clinical trials. They oversee hybrid working arrangements.

  • They utilize project management skills, processes, and tools to develop and execute local, regional, and global clinical trials.
  • Collaborate with other 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 responsible 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 Clinical Development.
  • Apply expertise and knowledge of global/regional regulations & Good Clinical Practice (GCP) to prepare and/or provide technical consultation for clinical and regulatory documents.
  • Utilize clinical development knowledge, problem-solving, and critical thinking skills to support the scientific needs of the business.

Required Skills and Qualifications:

  • Bachelor's or University degree (scientific or health-related field preferred) or an advanced degree.
  • Clinical trial experience with a strong working knowledge of the clinical research process.
  • Applied knowledge of clinical project management methodology, processes, and tools.
  • Demonstrated ability to work cross-culturally with global colleagues.
  • Strong leadership and networking skills.
  • Effective and influential communication, self-management, and organizational skills.
  • Proficiency in use of project management tools and techniques.

What We Offer:

This role offers a unique opportunity to contribute to the development and execution of clinical trials while working in a dynamic environment.

How to Apply:

Interested candidates should submit their application with relevant qualifications and experience.

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