Clinical Trial Project Management Associate / Senior Associate (Hybrid)

Location: Cork, Ireland

Permanent position/ Full time

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 enrolment 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.

• Partner with other organizations to coordinate and actively participate in Investigator Study Specific Training (ISSTs)/ Affiliate Study Training (ASTs).

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.
• 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.

Scientific Expertise

• 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:

• Bachelor’s or University degree (scientific or health-related field preferred) and 3 years of clinical research experience or relevant experience in a scientific or health-related field; or an advanced degree.
• Applied knowledge of project management methodology, processes and tools
• Strong leadership and networking skills exhibited while working in cross-functional and cross-cultural teams (internal & external) and on projects
• Effective and influential communication, self-management, and organizational skills
• Exploratory and biopharmaceutics clinical development experience preferred
• Proficiency in use of project management tools and techniques (e.g., Critical Chain, ProChain Enterprise, MS Project, MS Excel, MS PowerPoint)
• Ability to travel (up to 10% expected)