Head of Clinical Operations

Location
Dublin (Hybrid model)
Contract Type
Maternity Leave contract
Closing Date
November 4th 2021

Reports to:
CEO

Key Requirements

  • Bachelor’s degree in scientific discipline; advanced scientific degree preferred.
  • Minimum of 10 years in clinical research, including 3 years as head of department in a CRO or pharmaceutical company. Experience working in Oncology an advantage.
  • Proven track record of managing multiple clinical trials/programs from start-up to publication.
  • Proven Leadership skills.
  • Proven experience in line management and team development.
  • Experience in change management and process development desired.
  • Strong working knowledge of the Irish and European Clinical Research regulatory environment,
  • Demonstrated experience in managing budgets and contracts (operational and trial-specific)
  • In-depth knowledge of all functions involved in the clinical trial process.

Main Function(s)

  • Lead operational strategies and plans for clinical programs and functions through appropriate leadership, direction and expertise.
  • Responsible for ensuring clinical trials are managed according to all regulatory requirements, guidelines and SOPs efficiently and within budget.
  • Line Management and guidance of the Clinical Project Management team

Primary Responsibilities

  • Lead operational strategies and plans for clinical programs and functions through appropriate leadership, direction and expertise.
  • Responsible for ensuring clinical trials are managed according to all regulatory requirements, guidelines and SOPs efficiently and within budget.
  • Line Management and guidance of the Clinical Project Management team.

Primary Responsibilities

  • The execution of operational strategies of the Clinical and Pharmacovigilance functions and their alignment with Cancer Trials Ireland’s mission and strategy.
  • Lead and contribute to policy development and strategic planning of Cancer Trials Ireland.
  • Build and foster strong relationships with internal and external stakeholders such as Chief Investigators, internal committees, industry partners, funders, investigator/site research team members.
  • Oversight of the operation of committees with responsibility for the scientific direction of the clinical program, the safety and medical oversight of the study portfolio.
  • Lead and present ongoing operational plans and status reports to the CEO, Clinical Executive and Board, as required.
  • Identify program risks and develop and implement mitigation strategies.
  • Recruitment, development and succession planning for staff with responsibility for study management.
  • Owner and author of SOPs relevant to study management.
  • Ensure staff are appropriately trained and comply with Cancer Trials Ireland policies, applicable SOPs and regulatory requirements and quality standards.
  • Represent Cancer Trials Ireland at national and international meetings and conferences, as required.
  • Perform other tasks as specified by the CEO.