Job Details: Senior Clinical Research Data Manager


JobsIreland
Jervis Street
Dublin 1
Senior Clinical Research Data Manager
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

Apply for this Job Offer
Name:  *
Email:  *
Phone:  *
Don't forget to like:
 *
Cover Note
CV:  *
Are you human ?