Cancer Trials Ireland, is a national cancer research not-for-profit group set up by doctors and nurses working in our hospitals. The group organises cancer trials that test new and more effective ways to prevent, diagnose, and treat cancer. The vision is to provide every patient in Ireland with access to a trial and to grow the numbers currently on trials by 2026. In the last 20 years 30,000 Irish patients have been enrolled on a cancer trials, offering improved health outcomes.
Cancer Trials Ireland is seeking to hire a financial controller with a genuine interest in science, research and working in the not-for-profit sector. The complexity of clinical trials and the key role of finance within them makes this an excellent opportunity for someone with these interests and a proven strategic capability. These skills and interests will be brought to bear on an evolving approach to the Organisation’s finances. Following a period of successful consolidation our new financial controller, with an appreciation and respect for a trial’s clinical and scientific value, will take a more aggressive approach to opening new cancer clinical trials in Ireland.
Lead the overall development of the Finance Function and align it with the overall strategy for the organization. Oversee the full spectrum of financial and management accounting and the day-to-day financial operations.
Required Skills and Qualifications
- Qualified accountant (ACA/ACCA or equivalent) with a minimum 3 years’ experience
- Strong foundation in Financial Accounting, compliance with experience of initiating and driving projects to completion.
- Skills in development of revenue recognition policy
- Experience in clinical trials, pharmaceutical and/or charity/research sector
- Excellent, project management and process improvement skills including timesheet analysis.
- Proven leadership skills
- Demonstrated skills in presenting and managing Boards, Audit and other governance structures in charity and/or corporate sector
- Excellent presentation, interpersonal, written and verbal communication skills
- Proficient computer navigation skills using a variety of financial software packages eg TAS, Sage, Xero etc Advanced PC skills, particularly knowledge of MS Word and MS Excel software
- Manage the general ledger and financial reporting process, including monthly reconciliation, month-end and year-end closings.
- Prepare monthly financial statements: Income Statement, Balance Sheet, and Cash Flow Statement, following standard accounting practices.
- Prepare financial reports in conjunction with operations pertaining to the completion status and income in respect of trials
- Responsibility of Monthly Management and quarterly Board reports
- Budgeting and ongoing forecasting of completion status of trials.
- Manage financial aspects of all grant applications with funders and stakeholders
- Administer and report to the Audit Committee, Board and Clinical Executive Committee meetings.
- Ensure compliance with relevant statutory requirements and standards
- Continually review work practices and procedures for better operational efficiency; and potential issues in accounts, financial processes and controls and proactively raise management attention to act and resolve
- Develop and enhance processes for Revenue Recognition, reporting infrastructure and key performance indicators
- Strategy – Supporting senior management in further developing the strategic direction and growth of the business.
- Collaborate with stakeholders in the business to drive cross functional performance improvements.
- Preparation of annual budgets for presentation to the Board / Senior Management Team.
- Liaise with external financial auditors for the preparation of annual statutory accounts.
- Identify and deliver ways to enhance and automate existing processes.
- Work closely with senior management and board for various financial and commercial updates / presentations as required.
- Develop and document business processes and accounting policies to maintain and strengthen internal controls
- Create strong business partnerships and manage service levels with senior internal stakeholders and external third-party service providers.
- Supervision and line management of Assistant Accountants (2)
- Qualified Solicitor (or have a professional legal qualification) with at least 5 years’ post qualification experience.
- Knowledge of legal framework regulating trials.
- Experience of advising on data protection matters.
- Experience in a research or health related environment.
- Have extensive knowledge and experience of contract drafting.
- Proven experience of providing practical, solution-focused legal advice.
- Excellent report writing skills.
- Excellent organisational and communication skills.
- Sound decision making and administrative ability.
- Good team working skills and flexibility approach.
- High level of initiative.
- To provide advice on commercial, contractual and company law matters.
- To manage the drafting, negotiation and review of all legal documentation in relation to Cancer Trials Ireland and liaise with third parties as required.
- To draft contracts and develop template and other legal policies and procedures for Cancer Trials Ireland as required.
- To provide pragmatic, solution focused legal advice in areas such as clinical trials, data protection, employment law, regulatory and other matters as may be required.
- To assist in the development of template agreements, protocols and policies in relation to Cancer Trials Ireland.
- To advise generally on indemnities, liabilities and warranties.
- To advise in relation to research, commercial and other contracts which may include consultancy agreements, service agreements, confidentiality agreements, clinical trial agreements and other agreements to enable Cancer Trials Ireland’s activities.
- To bring forward enabling proposals to support the ongoing objectives and practices of Cancer Trials Ireland.
- To identify new and changing compliance requirements and assist with communicating, providing solutions and training as appropriate.
- Be proactive in contributing to the legal risk management for Cancer Trials Ireland.
- Ad hoc duties, as requested from time to time.
Management of Guidelines/Reports:
- To provide guidelines on legal issues and contractual templates.
- To provide workshops on relevant legal issues as requested.
- To provide reports as requested on activities carried out.
- To undertake regular research data collection and analysis of legal policy provision and development.
- Actively collaborate internally and externally to ensure efficient contract methodology and develop capabilities and capacity across Cancer Trials Ireland.
- Represent Cancer Trials Ireland at national and other meeting/events as required.
Clinical Operations Lead
- Science and/or medical or nursing background.
- Comprehensive knowledge of Clinical Research quality standards and Irish/European/ international regulatory requirements.
- Minimum of 5 years’ experience working in a clinical research organisation or Sponsor environment.
- Experience as a Senior or Lead Clinical Research Associate required, oncology an advantage.
- Experience in line management and team resource planning required.
- Understanding of the commercial environment and experience in study budgeting.
- Line manage assigned staff in line with Cancer Trials Ireland policies, Standard Operating Procedures (SOPs) and/or other Sponsor SOPs if applicable.
- Lead training and the career development pathway of clinical research staff including Clinical Trials Administrators (CTA), Clinical Research Associates (CRA) and Clinical Trial Coordinators (CTC)
- Maintain knowledge and ensure compliance with ICH-GCP, regulatory requirements, applicable guidelines, and SOPs.
- Manage optimal resourcing of clinical research staff and the planning and forecasting of clinical resource requirements including liaising with external Sponsors regarding the resourcing of externally sponsored studies.
- Manage the productivity of all clinical staff including Clinical Trials Administrators, Clinical Research Associates and Clinical Trial Coordinators.
- Develop and execute Training and Development plans for assigned clinical research staff.
- Manage Performance Reviews of assigned clinical research staff.
- Conduct in-house and on-site training of assigned clinical research staff.
- Lead the CRA forum.
- Manage Resource Planning of assigned clinical research staff.
- Collaborate with project teams, finance department and the Head of Clinical Operations on resource requirements for specific projects according to study-specific budgets and forecasting resource planning.
- Collaborate with Human Resources (HR) and external agencies in the recruitment of new clinical research staff.
- Oversee mentoring arrangements of assigned clinical research staff as required.
- Maintain strong relationships with external stakeholders including external Sponsors.
- Identify and escalate HR issues and manage the resolution process as required.
- Ensure compliance with all applicable Cancer Trials Ireland policies, SOPs and/or other Sponsor SOPs if applicable.
- Input into policy and SOP development and updates where appropriate.
- Take all reasonable precautions to ensure patient confidentiality is maintained.
- Organise and attend meetings as required.
- Prepare and make presentations as required.
- Identification and communication of scientific misconduct.
- Perform other tasks as specified by the Head of Clinical Operations.
Clinical Trials Administrator
- Full working knowledge of and competence with Microsoft Office.
- Proven organisational skills.
- Working knowledge of clinical trial process an advantage.
- Science or nursing qualification
- To carry out administrative duties on assigned studies in line with ICH-GCP, applicable regulatory requirements and guidelines, SOPs, study protocols and study-specific procedures.
- To provide additional administrative support to Clinical Operations Department and office where required.
Primary Responsibilities may include
- Preparation of Trial Master Files and Investigator Site and Pharmacy Files, including printing, filing, and tracking of clinical trial documents.
- Serving as administrator of the Trial Master File with direction from Project Management, including the preparation, maintenance, and archiving of the TMF.
- Coordinate the preparation, collection, tracking and filing of essential documents including centralised documents (Investigator/ investigational site staff CVs, Investigator Agreements, GCP certificates, laboratory accreditation, etc.)
- Preparation of site-specific study documents, including patient related documents under the guidance of the Clinical study team.
- Collating and sending clinical trial documents to hospital sites and Sponsor. Ordering and tracking of clinical trial supplies and investigational product.
- Assist in the logistics for bio-sample shipments.
- Processing study subject registrations for Cancer Trials Ireland studies.
- Responsible for main reception phone, stationary supply and other office tasks as part of the office administration team.
- Coordinate queries and direct issues to appropriate clinical research personnel.
- Assist Data Management with collation and tracking of Case Report Forms (CRFs), including generation of specific Data Management reports.
- Organise meetings, prepare agendas and minutes.
- Assist with training administration and preparations for training courses.
- Handle Cancer Trials Ireland membership requests; assist in update and maintenance of Cancer Trials Ireland membership details.
- Input into SOP development where appropriate.
- Contribute to preparation for audits and inspections as required.
- Perform other tasks as assigned.
Good clinical practices, Science degree, Organisational Skills, Microsoft, Excel
Clinical Trial Coordinator
- Science and/or medical or nursing background.
- Previous Medical or Clinical Research experience.
- Proven ability to deliver project goals and mentor junior level employees.
- Maintain knowledge and ensure compliance with ICH-GCP, regulatory requirements, applicable guidelines, SOPs (Standard Operating Procedures), study protocols and project-specific procedures.
- Coordination of clinical trial activities for assigned studies in line with ICH-GCP, applicable regulatory requirements and guidelines, study protocols and study-specific procedures, Cancer Trials Ireland SOPs and/or other Sponsor SOPs if applicable.
- Develop and maintain strong working relationships with external stakeholders/Sponsors.
- Manage and coordinate assigned studies, including development of country specific documents and overseeing regulatory and ethic committee applications.
- Primary contact for Sponsor and collaborator groups for assigned studies.
- Manage project-specific training and mentoring.
- Contribute to preparation for audits and inspections as required.
- Evaluate and document investigator and site selection as applicable.
- Overall responsibility for management of essential documents and Trial Master File where applicable.
- Responsible for the completion of study initiation, monitoring and close-out as required by the study.
- Identify issues and manage the resolution process for studies under their coordination.
- Ensure compliance with all applicable Cancer Trials Ireland and/or other Sponsor SOPs if applicable for all studies under their coordination.
- Input in SOP development and updates where appropriate.
- Ensure budget agreements and contracts are in place and roles and responsibilities documented prior to commencing study activities.
- Manage the study budget and associated financial activities for assigned studies where applicable.
- Organise, participate in and present at meetings and discussions with other teams and team members.
- Update Head of Clinical Operations and Project Manager where applicable for assigned studies on the status of all clinical trial activities.
- Prepare study reports as required.
- Perform other tasks as specified by Line Manager
If you are interested in any of these positions, please apply on irishjobs.ie or directly to Ide Fagan @ firstname.lastname@example.org