Clinical Trial Project Manager

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January 13, 2021
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January 13, 2021

Clinical Trial Project Manager

  • Permanent
  • Cork
  • Posted 1 week ago

The Clinical Trial Project Manager (CTPM) Associate leads the cross-functional study team in the development and execution of clinical trials and is accountable both regionally and globally to deliver trial(s) with quality, on time, and within scope and budget.

The CTPM Associate leverages project management, regional operational knowledge, clinical trial process leadership and expertise, and scientific expertise to drive actions and coordinate efforts to achieve or exceed these trial deliverables.

Project Management, and Regional Operational Knowledge

  • Use project management  skills, processes and tools to develop and execute local, regional and/or global clinical trials as described below:
    • Scope – Understand the scope of work required to complete the clinical trial successfully. Monitor the status and make changes (per change control process) as needed to meet the deliverables of the trial.
    • Timeline – Develop and track global trial enrollment plan by gaining alignment and integrating inputs across functions and geographies.
    • Risk – Assess, identify and monitor trial-level risks.  Incorporate scientific knowledge, trial process, and regional expertise to create one integrated trial-level risk mitigation and contingency plan.
    • Budget – Understand the cross-functional, trial-level budget components.  Create and monitor the overall budget and assumptions using financial tracking tools.  Routinely network with appropriate business partners, on trial-level budget status and changes.

Clinical Trial Process Leadership and Expertise

  • Demonstrate understanding of drug development process.  Acknowledge inter-relatedness of cross-functional activities and understand the impact of project decisions on the overall clinical trial. Look for opportunities to expand and deepen clinical trial process expertise.
  • Be knowledgeable of the global and regional operating model; coordinate and facilitate obtaining regional input to provide to the study teams.
  • Single point of accountability for the Trial Master File, working closely with functional record owners to ensure the file is current and inspection ready at all time.
  • Network and leverage expertise to anticipate trial and regional issues, identify areas of process breakdown, assess situations and propose proactive approaches that reduce and/or mitigate risks that impact ability to deliver the clinical trial.
  • Demonstrate ability to lead and influence in the midst of ambiguity.
  • Coach peers, cross-functional team members and TPOs on aspects of clinical trial process and regional specificities.
  • Report, manage and interpret information for the clinical trial(s), including completeness and accuracy across multiple business systems and tools from study implementation through closure.
  • Apply expertise and knowledge of global/regional regulations, Good Clinical Practice (GCP) and Lilly standards of operation in the conduct of clinical trials. Liaise with affiliates and other appropriate resources to understand local regulatory requirements.

Scientific Expertise

  • 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, TPOs 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.

Minimum Qualification Requirements:

  • Bachelors or University degree (scientific or health-related field preferred) and 3 years clinical research experience or relevant experience  in a scientific or health-related field; or an advanced degree.

Other Information/Additional Preferences:

  • Minimum of 3 years clinical trial experience with a stong working knowledge of the clinical research process
  • Prior clinical trial site-level or affiliate experience
  • Proficiency in use of project management tools and techniques (e.g., Critical Chain, ProChain Enterprise, MS Project, MS Excel, MS Powerpoint)
  • Need to travel periodically to AST/ ISST and potentially other scientific/ regional meetings
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