1. Main Purpose of Job
The Head of Core Services is a senior leadership role and will be responsible for ensuring core clinical research supports are developed, accredited and deployed to support ongoing University Research activity. They will develop recharge plans to ensure cost recovery and take responsibility for managing the finances of the clinical trials unit. This post is critical to the deployment of supports in a responsive, yet sustainable manner, underpinning the objectives of the Institute.
This role will need to be filled by an experienced research professional, with significant experience in core services, principally the postholder will:
- Develop the plan for core services for the Institute for Clinical Trials in statute, including, but not limited to
- Clinical Trial Design consultancy
- Statistical Analysis Plan
- Data Management Plans
- Regulatory Support
- Data Management
- Create cost models for the above services to ensure cost recovery
- Manage risk by ensuring excellence in trial operations
- Establish operational policies, SOPS and work instructions, for the core services that will ensure compliance
- Establish and maintain aspects of the quality system that support the operational activities of the Institute for Clinical Trials
- Work closely with colleagues as part of the operational leadership team.
- Co-lead on the development of a business plan/strategy for industry collaborations in clinical trials and clinical investigations.
- Provide leadership to the core service staff across the institute
2. Main Duties and Responsibilities
· Lead core research supports across the University of Galway Institute for Clinical Trials
· Manage the extended support team as part of the operations leadership group
- Lead the development of budget models and recharging plans for core services as previously described.
- Participate in discussions regarding the approval of studies for conduct at the Institute
- Manage resources to ensure the core supports are utilised to their maximum potential and have the greatest impact.
- Monitor operational activity to ensure targets are being met and compliance assured
- Assist in design and implementation of corrective measures as required
- Liaise, consult and ensure consistent communication across all clinical research stakeholders at the University of Galway
- Participate and assist in the co-ordination of governance and management meetings, including but not limited to, study operational meetings, operations leadership team meetings, executive team meetings and pan-institutional senior stakeholder governance meetings.
- Identify strategic opportunities for University of Galway to advance healthcare in Ireland through research and work with research leaders to deliver on these.
- Facilitate effective communication of complex study information with all relevant research personnel, including: medical, nursing, administrative and pharmacy staff, as required.
- Participate in teaching programmes for staff as required.
- Act as role model, encouraging staff to develop new ways of working and provide mentorship to junior staff
- Recognise and use spontaneous and formal learning opportunities and share knowledge and experience with other staff.
- The appointee will have a number of direct reports across the core supports teams
3. Requirements for the role:
The successful candidate will demonstrate the eligibility requirements below in terms of qualification, skills and experience:
· Level 9 in Health or life Sciences
· 7+ years’ professional experience working in large research performing organisation in a project management/operations role.
· Previous experience in the management of research projects, budgets and financial reporting.
· Demonstrable understanding of clinical trials, including regulatory and compliance requirements
· Significant experience in identifying and evaluating operations requirements, and in the implementation of those requirements.
· Strong ability to identify income generating activities for the Institute for Clinical Trials
· Superior ability to build effective working relationships, and encouraging co-operation and collaboration across and within multiple activities.
· Exceptional ability to maintain performance, responding accurately and effectively under time and technical pressures.
· Demonstrated excellent written and oral communication skills
· Experience of stakeholder engagement, responding to the needs and managing expectations of partners.
· Experience in business planning
· Keen understanding of the research funding environment
€77,375 to €98,701 (applicable to new entrants effective from January, 2011) and in accordance with the terms and conditions of the University’s Remuneration policy.
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