Clinical Data Manager/Trial Co-ordinator

Overview

Post Title: Clinical Data Manager/Trial Co-ordinator

Post Status: Temporary Specified Purpose Contract– Maternity Leave Cover

Department: Cancer Clinical Trials & Research Unit (CCTU)

Location: Beaumont Hospital, Dublin 9

Reports to: Programme Manager CCTU

Salary: Appointment will be made on Grade V salary scale (€51,206 - €61,253 LSI) at a point in line with Government pay policy.

Hours of work: Full-Time. 35 Hours Per Week

Closing Date: 12 noon on 17/3/2025

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

Position Summary:

The Clinical Data Manager (CDM) works as a team member to support the work of the Cancer Clinical Trials & Research 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 CDM will support the practice and development of the clinical research programme of Beaumont Hospital Cancer Services and its affiliates. The CDM will support 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 that all necessary training and education has been undertaken by relevant team members; maintaining records of study tests/procedures undertaken.

The Clinical Data Manager will be responsible for data management of an assigned portfolio of clinical trials and assist the Programme Manager with the implementation of quality improvement initiatives within the clinical trials unit. The CDM will carry out study specific duties as delegated by Principal Investigators and liaise with external organisations, Pharmaceutical companies and Co-ordinating Bodies as required. The CDM will provide support to and cover for his/her administrative colleagues as required. Attendance at external meetings may be required from time to time. Other duties will be assigned from time to time by the CCTU Programme Manager.

Responsibilities

1. Study Start –up

- Prepare documentation for start-up e.g., CVs, FDFs, 1572 forms, equipment specifications, and calibration records, training and education records, and other documentation as required by sponsor.
- Create and maintain 'potential study' folders – hard copy and electronic and prepare them for handover to the assigned CDM at start-up.
- Maintain 'Potential study' database.
- Prepare and maintain spreadsheets for capture and recording of study tests and procedures for reimbursement to The CCTU, BPC, Beaumont Hospital and other stakeholders as required.
- Facilitate the smooth initiation of clinical trials and facilitate early recruitment, ensuring the required study specific information is sought from sponsor, that mandated training is undertaken by the research team, and all relevant information recorded for start-up.
- Prepare study folders and Site File for initiation.
- Complete pre-start-up documentation.
- Ensure study specific 'Start-up Checklists' are completed by the relevant team members and presented to the CCTU Medical Director for review in a timely manner.
- Maintain database for study specific bi-annual Site File review/internal audit.

2. Data Management

- In liaison with the assigned Clinical Research Nurse, assume primary responsibility for the collection of clinical trial data and entry of such into Case Record Forms (CRFs) or study specific databases for assigned studies.
- Facilitate data collection to achieve goal of 100% capture rate and accuracy of cancer clinical trials data.
- Assist the Investigator with completion of Serious Adverse Event Reports.
- Respond to data queries and Monitoring visit reports in a timely manner.
- Take primary responsibility for ensuring all deviations and violations are recorded on site study specific forms, ensuring that CA/PA (Corrective action/Preventative action) is documented as agreed with the Team and Programme Manager.
- Ensure the Programme Manager is updated on study deviation trends, violations and other quality issues as identified.
- Provide feedback to Programme Manager and PIs on an ongoing basis if deficits in source documentation are noted.
- Ensure upkeep of Site Files for assigned studies according to ICH-GCP.
- Facilitate monitoring visits by Clinical Research Associates.
- Assist with internal and external audits as required.
- Maintain the storage of study & patient records in accordance with policy.
- Perform general Administrative duties as required: e.g., preparing meeting agendas & recording of minutes, collecting and sorting the post, general filing, photocopying, scanning and faxing of documents.

3. General

- Ensure the Programme Manager is kept updated on any sponsor concerns highlighted at monitoring visits or at any stage throughout the study.
- Develop and implement systems to facilitate good housekeeping within the Cancer Clinical Trials office.
- Responsible for ensuring all study documentation conforms to Ethics and Regulatory requirements.
- Assist the Programme Manager with developing and maintaining SOPs.
- Provide cover for colleagues as required.
- Compile and prepare reports/updates on clinical trial activity as required.
- Set up standard queries to facilitate data reporting.
- Maintain recruitment databases and complete patient & study data records as required by Programme Manager.
- From time to time the CDM may be required to carry out other functions or roles as delegated by the Programme Manager or CCTU Medical Director.

4. Education and Training

- Assist the Programme Manager to prepare Induction Programmes for new staff.
- Assist in educating and training of new staff.
- Keep yourself informed of changes within the Irish and European Regulations governing Clinical Trials.

This job profile is not to be viewed as an inflexible specification but as an outline of the principal duties and responsibilities applicable at present. The duties of the post may change from time to time in response to organisational priorities and in consultation with the post holder.

Qualifications

Selection Criteria: Selection criteria outline the qualifications, skills, knowledge and/or experience that the successful candidate would need to demonstrate for successful discharge of the responsibilities of the post. Applications will be assessed on the basis of how well candidates satisfy these criteria.

Mandatory

In exercise of the powers conferred on me by Section 22 of the Health Act 2004, I hereby approve the qualifications, as set out hereunder, for the appointment and continuing as Staff Officer, Grade V in the HSE.

1. Professional Qualifications, Experience, etc

- Eligible applicants will be those who on the closing date for the competition: (i) Have satisfactory experience as a Clerical Officer in the HSE, TUSLA, other statutory health agencies, or a body which provides services on behalf of the HSE under Section 38 of the Health Act 2004.
- Or (ii) Have obtained a pass (Grade D) in at least five subjects from the approved list of subjects in the Department of Education Leaving Certificate Examination, including Mathematics and English or Irish. Candidates should have obtained at least Grade C on higher level papers in three subjects in that examination.
- Or (iii) Have completed a relevant examination at a comparable standard in any equivalent examination in another jurisdiction.
- Or (iv) Hold a comparable and relevant third level qualification of at least level 6 on the National Qualifications Framework maintained by Qualifications and Quality Ireland (QQI).

Note: Candidates must achieve a pass in Ordinary or Higher level papers. A pass in a foundation level paper is not acceptable. Candidates must have achieved these grades on the Leaving Certificate Established programme or the Leaving Certificate Vocational programme. The Leaving Certification Applied Programme does not fulfil the eligibility criteria.

and

1. Age

Age restriction shall only apply to a candidate where s/he is not classified as a new entrant (within the meaning of the Public Service Superannuation (Miscellaneous Provisions) Act, 2004). A candidate who is not classified as a new entrant must be under 65 years of age on the first day of the month in which the latest date for receiving completed application forms for the office occurs.

1. Health

Candidates for and any person holding the office must be fully competent and capable of undertaking the duties attached to the office and be in a state of health such as would indicate a reasonable prospect of ability to render regular and efficient service.

1. Character

Candidates for and any person holding the office must be of good character.

Desirable

- Third Level Qualification – Science /Health Science or equivalent
- Experience with oncology / haematology trials desirable
- Experience and training in Good Clinical Practice (ICH/GCP) desirable
- Experience with RDC platforms such as Medidata RAVE, INFORM, etc desirable
- Versatile, highly organised and ability to work to deadlines
- Must be a team player and possess the ability to work on own initiative

Informal Enquiries ONLY to:

Name: Keith Egan

Title: Programme Manager CCTU

Telephone: (01) 8092010

Email: keithegan2@beaumont.ie

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