Clinical Standards Consultant

Clinical 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 Standards governance advisor to oversee the re-build of a high volume of trials globally.


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
• Good organizational skills, problem-solving abilities, time management skills and initiative.
• Flexibility and ability to work on several assignments simultaneously. Must be able to work independently as well as part of a team.
• Good written and oral communications skills in the English language.
• Excellent interpersonal communication skills.
• Experience with Medidata Rave will be a huge asset 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.