LOCATION: CORK, IRELAND (FUNDED RELOCATION PACKAGE)

Responsibilities

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.

• 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 affiliate, site, and investigator training
• Drive and coordinate local, regional and global, cross-functional study team throughout study implementation, execution, and closure, empowering them to meet the clinical trial deliverables, including issue management, contingency planning and issue resolution.
• 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, CDDA, and Third Party Organization (TPOs).
• Manage TPO 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
• 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.

• 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.

Basic Qualifications

• Bachelors or University degree (scientific or health-related field preferred) or an advanced degree.

Additional Skills/Preferences

• 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
• Clinical trial experience with a strong working knowledge of the clinical research process.
• Proficiency in use of project management tools and techniques (e.g., Critical Chain, MS Project, MS, Excel, MS PowerPoint)