Standards Support Specialist

Premier Research

Standards Support Specialist working with biotech, medtech, and specialty pharma companies. Assisting in clinical data management processes and ensuring compliance with data standards.

Posted 5/26/2026full-timeRemote • 🇧🇬 BulgariaJuniorMid-LevelWebsite

Tech Stack

Tools & technologies

Oracle

About the role

Key responsibilities & impact

Populates the Metadata Repository based on approved impact assessments and/or Case Report Form (CRF) specifications and annotations
Creates CRF specifications and annotations based on impact assessments and documented decisions
Populates the metadata in the global library of the clinical data management system (CDMS)
Creates new graphic CRF modules based on approved impact assessments
Posts Data File Specifications, Statistical Guidance Documents, and other related documents to the Metadata Repository
Manages the standards work flow change control process via the change control system
Trains and follows internal and sponsor's standard operating procedures as applicable
Liaison with the sponsor as needed to resolve issues that cannot be resolved within the organization
Performs additional duties as assigned

Requirements

What you’ll need

Bachelor degree, or international equivalent from an accredited institution, preferably in a technical field or equivalent combination of education, training and experience
2-3 years of practical experience using commercial clinical data management systems and/or EDC products (eg - Oracle RDC / Inform, Medidata Rave, DataLabs, etc)
Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities
Demonstrates excellent English verbal and written communication skills
Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownership
Familiarity with Clinical Data Interchange Standards Consortium (CDISC) standards preferred

Benefits

Comp & perks

Working hours: 11am-7pm, Monday to Friday

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

metadata managementimpact assessmentsCRF specificationsdata file specificationsstatistical guidancechange control processclinical data management systemsEDC productsanalytical skillsproject management

Soft Skills

organizational skillsindependencecommunication skillscustomer experiencetask ownershipproblem-solvingcollaborationadaptabilityattention to detailtime management

Certifications

Bachelor degreeaccredited institution