Title: Head of Clinical Operations
Reports to: Chief Executive Officer (CEO)

 

Key Requirements

 

  • Bachelor’s degree in scientific discipline; advanced scientific degree preferred.
  • Minimum of 10 years in oncology clinical research, including 3 years as head of department in a CRO or pharmaceutical company.
  • Proven track record of managing multiple clinical trials/programs from start-up to publication.
  • Proven experience in team management and 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 (operational and trial-specific),
  • In-depth knowledge of all functions involved in the clinical trial process,

 

Main Function(s)

  • Lead operational strategies for clinical programs and functions through appropriate leadership, direction and
  • Ensure clinical trials are managed according to all regulatory requirements, guidelines and SOPs, efficiently and within budget by providing oversight to the Clinical Project Management team.

 

Primary Responsibilities

  • Ensure execution of operational strategies of the functions Clinical, Biometrics and Pharmacovigilance and their alignment with Cancer Trials Ireland’s mission and strategy.
  • Lead and contribute to policy development, strategic planning and business development of Cancer Trials Ireland.
  • Collaborate with all Cancer Trials Ireland functions and departments.
  • 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 medical oversight of the study portfolio, and representation of the investigator/site network.
  • Oversee the preparation of funding applications and periodic reports to funders.
  • Provide and present ongoing operational plans and status reports to the CEO, Clinical Executive and Board as required.
  • Ensure effective development, implementation and execution of clinical programs within agreed timelines, resources and budget.
  • Oversee operational budgets and the management of variance, as applicable.
  • Identify program risks and develop and implement mitigation strategies.
  • Identify, recruit, hire, line manage, and develop staff with responsibility for study management through coaching, mentoring, performance management.
  • Line manage assigned staff in line with Cancer Trials Ireland policies, Standard Operating Procedures (SOPs) and/or other Sponsor SOPs if applicable.
  • Transition and succession planning.
  • Review and approve SOPs relevant to study management.
  • Ensure study management staff are appropriately trained and comply with Cancer Trials Ireland policies, SOPs and applicable regulatory requirements and quality standards, and act as a driver of continual improvement.
  • Create a positive work environment by encouraging mutual respect and accountability.
  • Attend training programs and represent Cancer Trials Ireland at national and international meetings and conferences, as required.
  • Perform other tasks as specified by the CEO.

 

Please send cover letter and CV to ide.fagan@cancertrials.ie