Data Standards consultant

Data Standards consultant - Remote role

My client is a leader in the Pharma industry setting the standards in clinical development globally. As part of their continued investment in ensuring the highest standards, we require a Data Standards consultant to develop project and company standard metadata structures and provide guidance and support.

Role

• Develop project and company standard metadata structures
• Provide support and knowledge to project teams on the company and industry standards (eCRF creation through to SDTM domains)
• Work in therapeutic area focus groups to align and improve processes
• Define and release company metadata structures within the MDR system
• Define and maintain EDC global library elements, including eCRFs, fields, data dictionaries, and procedure specifications
•  Reviewing Controlled Terminology under RAVE/MDR/SDTM systems

Experience

• You will be experienced within clinical standards within the Pharma or CRO/Vendor industry
• You will have an in-depth comprehension of CDISC standards
• Experience with Data mapping and eCRF creation through to SDTM domain
• Good written and oral communications skills in the English language.
• Excellent communication skills and able to work with cross-border teams
• Experience with RAVE is a plus but not essential

If you have the skills and experience and passion for this role, please get in touch for a confidential conversation. Initially, this will be a 24-month contract working remotely from home either based in the US or UK/Europe.