Clinical Data Standards Consultant

2 days ago


London, Greater London, United Kingdom ICON plc Full time
Job Description:

We are seeking a highly skilled Clinical Data Standards Consultant to join our team at ICON plc, a world-leading healthcare intelligence and clinical research organization. As a key member of our team, you will play a crucial role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.

The ideal candidate will have extensive experience in clinical data management and standards within the pharmaceutical or biotechnology industry. A Bachelor's degree in a relevant field, such as Life Sciences or Computer Science, is required. Proficiency in CDISC (Clinical Data Interchange Standards Consortium) standards and relevant regulations is also essential.

In this role, you will be responsible for developing tools to aid in the implementation and compliance of CDISC, Sponsor, and ICON standards. You will collaborate with cross-functional teams to define data collection strategies and standards for clinical trials. Additionally, you will develop and maintain training and reference materials related to standards topics, including CDASH, SDTM, Terminology, ADaM, define-XML, and regulatory submission requirements.

Responsibilities:
  • Developing tools to aid in the implementation and compliance of CDISC, Sponsor, and ICON standards
  • Collaborating with cross-functional teams to define data collection strategies and standards for clinical trials
  • Developing and maintaining training and reference materials related to standards topics
  • Managing the development and maintenance of data management processes and tools


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