Clinical Data Specialist - #1700115

Clinical Data Quality Specialist

Every member of the Celerion team is involved in making something essential – a distinctive contribution to the health and well-being of people around the world. That’s the sense of purpose shared by employees throughout Celerion. We’re an early phase drug research company, operating in robust and growing markets. We have an exciting future and offer a strong development environment for our excellent employees.

We are looking for a Clinical Data Specialist to join our clinic team in Belfast, N.Ireland.

This role is responsible for the review and verification of all clinical trial source data and will conduct data reconciliation and final checks before the data is sent to our Clinical Data Management team.  You will ensure the completeness, accuracy and consistency of source data so that it meets the standards of quality expected for reporting to Sponsors and regulatory bodies.   You will participate with multidisciplinary teams involved in setting up, conducting and reporting clinical trials.

Essential Functions:

For all assigned studies, ensure the following:

*Attend study setup meetings to determine Quality Control (QC) criteria and timelines for each study 

*Review study-specific source documents to ensure all forms are accurate prior to study start and that all data collected is in accordance with study-specific Case Report Forms and protocol requirements. 

*Ensure QC reviews are complete in accordance with study-specific timelines  

*Review source data on an ongoing basis to ensure the following: 

 o    Clinical source data is complete according to GCP and MHRA guidelines, protocol deviations (if applicable) are documented, and source data is collected in accordance with Sponsor requirements, and Celerion SOPs/PGs. 

 o    Ensure data corrections are completed according to GCP guidelines, and Celerion SOPs/PGs. 

 o    Complete a Final QC to ensure all source data is accounted for and has been QC reviewed 

*Perform accurate data entry (DE) and verification for Celerion Standard and Sponsor Provided EDCs. 

*Archive source documentation including CRFs 

*Complete QC/DE dedicated milestones in a timely manner 

*Perform standard quality control steps