Quality Improvement Officer/Data Management Lead

Overview

 

Post Title:

Quality Improvement Officer/Data Management Lead

Post Status:

Permanent Contract

Department

Cancer Clinical Trials & Research Unit

Location:

Beaumont Hospital, Dublin 9 

Reports to:

Accountable to the Programme Manager, Cancer Clinical Trials & Research Unit

Salary:

Appointment will be made on GRADE VII – CLERICAL (€59,419 - €77,243 LSI) at a point in line with Government pay policy. 

Hours of work: 

Full-Time - 35 Hours per week

Closing Date:

 

12 Noon on 19/3/2025

 

Please note the hospital reserves the right to close the competition early should a substantial number of applications be received.

 

 

Summary of Job 

 

The Quality Improvement Officer/Data-Management-Lead works as a team member to support the work of the Cancer Clinical Trials Unit (CCTU) and acts as a member of the multidisciplinary team, liaising with Medical and Nursing staff, Laboratory and Pharmacy Staff, Information Management Services and other departments as required. The Quality Improvement Officer/Data-Management-Lead supports the practice and development of the research programme within Beaumont RCSI Cancer Centre and its affiliates in line with the institutions ambitions to be a comprehensive cancer centre.

The post holder supports the Programme Manager by maintaining high quality standards in all aspects of clinical research, assisting with study start –up to ensure studies are opened in a timely manner and overseeing all necessary training and educational requirements. The post-holder is responsible for overseeing best-practice data management processes and assisting the Programme Manager with the implementation of quality improvement initiatives within the Cancer Clinical Trials & Research Unit. The post-holder carries out study specific duties as delegated by Principal Investigators and liaises with external organisations, Pharmaceutical companies and Co-ordinating Bodies as required.  The post-holder provides support to and cover for his/ her administrative colleagues as required, including the Programme Manager where necessary.   Attendance at external meetings may be required from time to time.

Other duties are assigned from time to time by the CCTU Programme Manager.

The Quality Improvement Officer/Data-Management-Lead is required to manage, co-ordinate and oversee a shift towards a less paper-based environment in preparation for a broadening of the trials portfolio and in view of a move towards electronic medical records, electronic prescribing and in support of electronic site file management. 

Responsibilities

 

 

Professional:

• Attend and participate in: In service and staff education, Staff conferences appropriate outside conferences and/or other professional development activities. 
• Participate in internal and external working groups to develop and share evidence based / best practice, locally, nationally and internationally if required. 
• Act as an ambassador for the CCTU and Beaumont RCSI Cancer Centre, taking opportunities to promote both areas and clinical research in general.

 

Education & Development:

• Participate in teaching programmes for CCTU research staff and the broader clinical research team on all aspects relating to delegated tasks.
• Recognise and use spontaneous and formal learning opportunities and share knowledge and experience with other staff.
• Continue to maintain and develop personal and management skills by undertaking mandatory and other training as required.
• Assist the Programme Manager in the development of induction programmes for new staff.

 

Finance:

 

Assist the Programme Manager with Finance Management:

 

• Prepare study specific finance spreadsheets at start-up.

 

• Ensure all reimbursable visits and information is captured

 

• Ensure all study specific tests & procedures are captured as per budget

 

• Prepare invoices as required by Programme Manager.

 

• Liaise with accounts department as required.

 

 

Quality:

 

• Oversee the introduction of an electronic site file across a broad portfolio of clinical research studies.
•  
• Drive the move away from paper-based environment with the adoption of electronic processes supported by internal and external means to facilitate greener approach to cancer trial management.
• Assist Programme Manager with the development and update of CCTU specific SOPs and Process Summaries.
• Oversee the reporting of non-conformance reports in line with European Regulation legislation
• Review of monitoring visit letters and feedback to Principal Investigators and core CCTU team on ways of improving data.
• Oversee ongoing trial specific training and updates 
• Oversee the capture of study-specific and unit specific metrics including but not limited to data-entry and patient-associated measurements. 
• Deliver on reporting requirements to Cancer Research Executive Committee, Beaumont RCSI Cancer Research Executive, and other committees where necessary and as obligated under grant provisions.
• Ensure that all Beaumont Hospital clinical, operational and research governance SOPs, policies and procedures are adhered to.  

 

Human Resources:

 

Participate in the hiring process for new staff

 

Cultivate and promote a positive working environment in which staff and research can thrive. 

 

Provide regular and timely feedback to encourage and motivate staff as well as developmental feedback where areas of improvement are noted.

 

Promote a culture of empowerment where staff are encouraged to make decisions appropriate to their role, level and experience.

 

 

Qualifications

 

Mandatory

 

Qualifications

 

• A third level qualification in healthcare / science / business or related area.
• A Master’s or PhD degree in a relevant field such as science, nursing or medicine

 

Knowledge & Experience

 

• Experience working in Oncology/Haematology Clinical Trials unit
• An excellent understanding of clinical research processes.
• Experience with electronic site files
• Familiarity with research legislation, regulatory frameworks, protocols and ethics
• Excellent communication skills - requires attention to detail and meticulous record keeping.
• Strong interpersonal skills, ability to work with a diverse research team and relate to a broad spectrum of research participants.
• Knowledge of key principles of ICH-E6 Good Clinical Practice
• Ability to work independently, self-directed but also work well within a team and under supervision and direction.
• Good IT skills including Microsoft Office, email and other clinical trial / data systems.

 

 

 

Informal Enquiries ONLY to: (Please note NO APPLICATIONS will be accepted via the Informal Enquiries email address)

Name:

   Keith Egan  

Title:

    Programme Manager

Email address:

    keithegan2@beaumont.ie

Telephone:

    N/A