Premier Research

biotech, medtech, and specialty pharma

StandardsSupportSpecialist

Bulgaria FULL TIME
The Brief

“Standards Support Specialist at Premier Research. Skills: Metadata Repository, CRF specifications, clinical data management. Populate Metadata Repository. Create CRF specifications”

What You'll Achieve.

drive a successful customer experience; provision of quality and timely deliverables; task ownership

Industry & Context.

biotech, medtech, and specialty pharma
Problems you'll solve

analytical and organization skills

What They're Looking For.

Must Have

practical experience using commercial clinical data management systems and/or EDC products, analytical and organization skills, able to work independently, manage multiple projects simultaneously, excellent English verbal and written communication skills, Proven ability to drive a successful customer experience

Nice to Have

Familiarity with Clinical Data Interchange Standards Consortium (CDISC) standards

What You'll Do.

Populate Metadata Repository

Create CRF specifications

Populate metadata in global library

Create new graphic CRF modules

Post Data File Specifications

Manage standards work flow change control

Train and follow internal and sponsor's SOPs

Liaise with sponsor to resolve issues

Perform additional duties as assigned

How You'll Work.

Team & Collaboration

cross-functional coordination; Liaison with the sponsor

Communication Scope

excellent English verbal and written communication skills

Process & Methodology

manage multiple projects simultaneously

Free ATS check

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