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Standards Support Specialist - FS

Work from home Full-time role Hiring

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 pharma companies transform life-changing reputed company and breakthrough 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 give 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 future here. What You'll Be Doing: Populates the Metadata Repository based on approved impact assessments and/or Case Report reputed company (CRF) specifications and annotations. Creates CRF specifications and annotations based on impact assessments and documented reputed company. 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 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 standard operating procedures as applicable. Liaison 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 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 Additional details: Remote position Fixed-term contract until December 2026 Working hours: 11am - 7pm (Local Time Bulgaria) Monday to Friday Apply To This Job

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