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Clinical Data Standard Specialist

3 months ago

Salem, United States AIXIAL GROUP Full time

The Aixial Group is an International Contract Research Organization (CRO), a member of the ALTEN Group, providing complex services in clinical trials (phase I-IV) and non-interventional studies. Our offices are located in France, Belgium, Switzerland, Germany, Denmark, Sweden, UK, Romania, US, India and Czech Republic.

The CRO occupies a unique position in the clinical research industry, not only as an expert in the operational delivery of clinical trials in complex disease areas including oncology, immuno-oncology, and cell therapy, but also as a developer of its own technologies for managing clinical data. This is a very exciting time to join as we are at the cutting edge, defining new and more efficient ways to design, capture, manage, review, and visualize clinical trial data.

We are currently looking for an enthusiastic and talented Clinical Data Standard Specialist / Clinical Governance Expert


Job Description


Job Title: Clinical Data Standard Specialist


Department: Clinical Information Governance


Tasks & Responsibilities:

Data Collection Data Steward for multiple therapeutic areas:

Support Clinical teams on a daily basis in their implementation and use of up-to-date Standards.

Oversee the evolution of standards both internally and in the wider industry.

Develops, updates and maintain the Clinical Data Standards Library, based on Business needs and in compliance with Industry Standards.

For Global releases, manage the harmonization of all Standards documents and load all the documentation in the CIG SharePoint.


Metadata Standard Analyst for multiple therapeutic areas:

Review all study-specific metadata for CRF / External Data to approve or modify implementation within the study.

Support the Data Collection Data Steward Leader and External Data Expert in CRF and data flows creation.

For Global releases, manage the harmonization of all Standards documents between DC/SDTM/CT/ADAM.


Environment: WISE, Rave Medidata