Senior Clinical Data Manager

Key Requirements 

• Experience and  training in  Good Clinical Practice (ICH/GCP)  mandatory
• Experience with electronic CRF systems (Inform, Oracle, Rave etc..) mandatory
• Experience working with Oncology and/or Haematology protocols
• Third Level Qualification – Science /Health Science and /or Management
• Have previously held a position as Clinical Data Manager with at least 2 years’ experience in Clinical trials

Job Background /Purpose

The Senior Clinical Data Manager (CDM) 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 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

Primary Responsibilities will include:

Study Start –up

Working closely with the Programme Manager the CDM will:

• Prepare documentation for start-up eg CV’s ,FDF’s, 1572 forms, equipment specifications and calibration records, training and education records and  other documentation as required by sponsor. 
• Maintain ‘Potential study’ data base as required
• To facilitate the  smooth initiation of the clinical trial and facilitate early recruitment ensure 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 as required
• Complete pre- start-up documentation where requested

Study Close Out

• Will assist CCTU in closure and archival of studies in a timely fashion
• Will organise COVs and follow up with required contacts to ensure all tasks completed in advance of study archival
• Ensure studies are archived for the required timeframes and ensure timely destruction when appropriate

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.
• Keep the Programme Manager and Investigators updated on study deviation trends, violations and other quality issues as identified.
•  Provide feedback to relevant staff on an on-going basis if deficits in source documentation are noted.
• 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 PI’S on an on-going 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: eg

Preparing meeting agendas & recording of minutes,

Collecting and sorting the post,

General filing, photocopying, scanning and faxing of documents. 

General

• Ensure the Programme Manager is kept updated on any sponsor concerns highlighted at monitoring visits or at any stage throughout the study.
• Developing and implementing systems to facilitate good housekeeping within the Cancer Clinical Trials office.
• Ethics and Regulatory
• Responsible for ensuring all study documentation conforms to Ethics and Regulatory requirements.
• Assist the Programme Manager with developing and maintaining SOP’s.
• Provide administrative cover for colleagues as required.
• Database Design / Maintenance
• 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.

Education Quality and Training

• Assist the Programme Manager to prepare Induction Programmes for new staff.
• Assist in educating and training of new staff.
• Oversee ongoing trial specific training and updates
• Keep yourself informed of changes within the Irish and European Regulations governing Clinical Trials.
• Act as Mentor to other Clinical Data Manager’s and other administrative staff.

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.

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 Section Officer, Grade VI
in the HSE.

1. Professional Qualifications, Experience, etc

(a) 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 Irish1. 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).
Note1:

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

(b) Candidates must possess the requisite knowledge and ability, including a high standard of
suitability, for the proper discharge of the office.

2. 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.

3. 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.

4. Character

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

To apply, please see top of page.