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
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). Alternately, must have proven experience in all primary job functions.
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
Additional details:
Remote position
Fixed-term contract until December 2026
Working hours: 11.30 am - 7.30pm (Indian time) Monday to Friday
Working hours: 11am - 7pm (Local Time Bulgaria) Monday to Friday
Benefits
Vision insuranceRemote work options
Additional Information
Premier Research is looking for a Standards Support Specialist - Fixed Term to join our Functional Services Provider (FSP) team.
You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
Your ideas influence the way we work, and your voice matters here.
As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Join us and build your future here.
Premierresearch · India