|Title:||Head of Clinical Operations|
|Reports to:||Chief Executive Officer (CEO)|
- 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,
- 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.
- 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 firstname.lastname@example.org