We offer a full range of consulting, clinical development and commercialisation services from a global network of offices in 46 countries
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 co...
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As a member of the Study Start Up Team, you will play an integral role in making sure that physicians at our research sites are prepared to start the trial of investigational, new pharmaceutical and biological products for clinical trials at their local practices.
Coordinate, balance and facilitate activities related to the completion of Critical Document Package (CDP) and the IP release checklist (SST004-SOP-F01) in accordance with ICH GCP guidelines and all applicable regulations, laws, ethical standards, other guidelines, sponsor requirements
Ensure that the overall process is focused on quality, efficiency and cost containment for a particular region / sub division within the CDP group, under the general mentorship of Mgr/Sr. Manager – Central Services or Designee.
What you need
Bachelor’s Degree preferably in Life Sciences
Minimum of 3 years’ experience or understanding of clinical study start up requirements and activities.
Experience of Clinical Trial operations and meeting regulatory guidelines
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