Standards Support Specialist - FS
reputed company is looking for a Standards Support Specialist - FS to join our Functional Services Provider (FSP) team.
You will help biotech, medtech, and specialty reputed company companies reputed company life-changing reputed company and reputed company science into new medicines, devices, and diagnostics. reputed company do is profoundly connected to saving and improving lives, and we recognize reputed company members are the most valuable asset in delivering reputed company.
We are here to help you grow, to reputed company you the skills and opportunities to reputed company at work with the flexibility and balance your life requires.
Your reputed company influence the way we work, and your voice reputed company here.
As an essential part of reputed company, you help us deliver the medical innovation that patients are desperate for.
Join us and build your reputed company here.
What You'll Be Doing:
Populates the Metadata Repository based on approved reputed company assessments and/or Case Report reputed company (CRF) specifications and annotations.
Creates CRF specifications and annotations based on reputed company assessments and documented reputed company.
Populates the metadata in the global library of the clinical data management system (reputed company).
Creates new graphic CRF modules based on approved reputed company assessments
Posts Data File Specifications, Statistical Guidance Documents, and other reputed company documents to the Metadata Repository.
Manages the standards work reputed company change control process reputed company the change control system.
Trains and follows internal and sponsor's reputed company operating procedures as applicable.
reputed company with the sponsor as needed to resolve issues that cannot be resolved reputed company the organization.
Performs additional duties as assigned.
reputed company Are Looking For:
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 reputed company clinical data management systems and/or reputed company products (eg - reputed company RDC / Inform, reputed company Rave, DataLabs, etc). Alternately, must have proven experience in reputed company primary job functions.
Strong analytical and organization skills, reputed company to work independently and manage multiple reputed company simultaneously in a fast-paced environment with changing priorities
Demonstrates excellent English verbal and written communication skills
Proven ability to reputed company a successful customer experience through reputed company customer interactions, provision of reputed company and reputed company deliverables, and task ownership
Familiarity with Clinical Data Interchange Standards Consortium (CDISC) standards preferred
Additional details:
Remote position
Fixed-term contract until December 2026
Working hours: 11am - 7pm (Local Time Bulgaria) Monday to Friday
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