Director, Clinical Risk Management

ICON Clinical Research
Closing date
28 Sep 2020

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Data Management / Statistics, Clinical Data Management
Full Time
Contract Type
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Director Clinical Risk Management

Clinical Risk Management is a group of two teams: CRM Development and the Clinical Data Analyst team who perform central monitoring.

The CRM Development team build visualizations of clinical data in ICONik - these visualizations enable Medical Data Review via the Medical Data Review pack and Clinical Data Analysts perform their analysis using the Clinical Data Review pack.

ICONik is the system name for the environment where the CRM Development team work: clinical data is mapped to a data standard and stored in the Clinical Data Repository (CDR) which is an Oracle database. ICONik uses Spotfire as the visualization tool for the CDR.

A number of Leads in the CRM Development team work on a Sponsor FSP using Cluepoints a commercial available Risk-based Quality Management system.

The Director of Clinical Risk Management would lead the CRM Development team (ICONik + Sponsor FSP with Cluepoints).

This role involves:
  • Working closely with the Clinical Risk Management Leaders on Clinical Risk Management Strategy
  • Managing a team of Managers, Leads and Developers working on ICONIk and Cluepoints Deployments
  • Optimizing ICONik Project Delivery and Resources
  • Development of ICONik Strategy
  • Business Development Activities - presentations to clients, bid defences, study budgeting
  • People and Project Management skills
  • Clinical Development experience (e.g. Clinical Monitoring, Clinical Risk Management, Data Management) and/or Software Development Lifecycle experience highly desirable.

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life.

We are a global provider of outsourced development and commercialisation services to pharmaceuticalbiotechnologymedical device and government and public health organisations. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas. ICON has been recognised as one of the world’s leading Contract Research Organisations through a number of high-profile industry awards.

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