fixed-term contract position as a Senior Data Manager within the HRB
Clinical Research Facility at the National University of Ireland,
Galway (CRFG). The position is available immediately for a period of
one year, with potential to extend subject to project success and
funding acquisition.
This position includes flexibility around remote working as an option.
Duties:
* Contribute to the design/review of study protocols (including
amendments) and provide input to the clinical trial team on data
management issues.
* Work across a portfolio of different studies, implementing
efficiencies and consistencies across each protocol
* Assist in standardising data management procedures and data
definitions within the programme of studies and the wider department
* Prepare clinical trial documentation including but not limited to
data management plans, updating tracking systems, creating trial
master files (TMF), maintenance of TMF and any other appropriate study
documentation.
* Design case report forms and ensure effective management of their
generation and quality control, ensuring consistency across a
programme of studies.
* Define database requirements and data validations.
* Prepare Case Report Form (CRF) completion instructions and present
material for clinical trial activities at investigator meetings and
site initiation visits.
* Train site personnel to help improve the quality of the data being
collected.
* Assist with the development of training programs for Principal
Investigators and research staff in data management.
* Generate accurate data clarification requests and track all queries
through their resolution and filing in the CRF.
* Ensure compliance with all applicable legislation, regulations and
guidelines (e.g. ICH-GCP, EU clinical trial legislation, ISO
standards, etc.)
* Review, analyse, and validate clinical research data to ensure
consistency, integrity and accuracy based on project specific
guidelines in preparation for abstract submissions/publications
* Develop budgets and data management resource requirements across
studies
* Support and contribute to submissions for research funding by
providing input on Clinical Research Data Management requirements,
including contribution to estimating costs and resources required.
* Encode all clinical data in agreement with PI and statistician.
* Ensure appropriate and timely communications with investigative
sites in the collection, entry, management, quality control and
analysis of data, as required by investigators and sponsors.
* Ensure that Standard Operating Procedures (SOPs) are followed.
* Undertake additional data activities as assigned by a Line Manager
Qualifications/Skills required:
Essential Requirements:
* University degree or equivalent professional experience (minimum 5
years)
* Minimum 5 years relevant work experience in a clinical research data
management related role.
* Experience of managing resources and budgets in a management role.
* Evidence of knowledge of clinical research, associated processes and
regulations
* Proven ability to demonstrate a good and confident command of spoken
& written English, sufficient to successfully discuss and explain
complex technical ideas in simple & concise terms to a diverse range
of stakeholders
Desirable Requirements:
* An IT qualification (Knowledge of SQL, Java, Python or similar would
be useful but not essential)
* Nursing qualification or Life science qualification
* Management Experience
* Nursing experience
* ICH-GCP Training Applications are invited from suitably qualified candidates for a
fixed-term contract position as a Senior Data Manager within the HRB
Clinical Research Facility at the National University of Ireland,
Galway (CRFG). The position is available immediately for a period of
one year, with potential to extend subject to project success and
funding acquisition.
This position includes flexibility around remote working as an option.
Duties:
* Contribute to the design/review of study protocols (including
amendments) and provide input to the clinical trial team on data
management issues.
* Work across a portfolio of different studies, implementing
efficiencies and consistencies across each protocol
* Assist in standardising data management procedures and data
definitions within the programme of studies and the wider department
* Prepare clinical trial documentation including but not limited to
data management plans, updating tracking systems, creating trial
master files (TMF), maintenance of TMF and any other appropriate study
documentation.
* Design case report forms and ensure effective management of their
generation and quality control, ensuring consistency across a
programme of studies.
* Define database requirements and data validations.
* Prepare Case Report Form (CRF) completion instructions and present
material for clinical trial activities at investigator meetings and
site initiation visits.
* Train site personnel to help improve the quality of the data being
collected.
* Assist with the development of training programs for Principal
Investigators and research staff in data management.
* Generate accurate data clarification requests and track all queries
through their resolution and filing in the CRF.
* Ensure compliance with all applicable legislation, regulations and
guidelines (e.g. ICH-GCP, EU clinical trial legislation, ISO
standards, etc.)
* Review, analyse, and validate clinical research data to ensure
consistency, integrity and accuracy based on project specific
guidelines in preparation for abstract submissions/publications
* Develop budgets and data management resource requirements across
studies
* Support and contribute to submissions for research funding by
providing input on Clinical Research Data Management requirements,
including contribution to estimating costs and resources required.
* Encode all clinical data in agreement with PI and statistician.
* Ensure appropriate and timely communications with investigative
sites in the collection, entry, management, quality control and
analysis of data, as required by investigators and sponsors.
* Ensure that Standard Operating Procedures (SOPs) are followed.
* Undertake additional data activities as assigned by a Line Manager
Qualifications/Skills required:
Essential Requirements:
* University degree or equivalent professional experience (minimum 5
years)
* Minimum 5 years relevant work experience in a clinical research data
management related role.
* Experience of managing resources and budgets in a management role.
* Evidence of knowledge of clinical research, associated processes and
regulations
* Proven ability to demonstrate a good and confident command of spoken
& written English, sufficient to successfully discuss and explain
complex technical ideas in simple & concise terms to a diverse range
of stakeholders
Desirable Requirements:
* An IT qualification (Knowledge of SQL, Java, Python or similar would
be useful but not essential)
* Nursing qualification or Life science qualification
* Management Experience
* Nursing experience
* ICH-GCP Training
We need : English (Good)
Type: Permanent
Payment:
Category: Others
