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Posted 3 days agoSenior External Data Specialist - FSP
at Fortrea
Warsaw, PolandOn-site
Responsibilities
- Support review, maintenance, and management of external vendor data (central labs, local labs, and other third-party sources)
- Develop and maintain Vendor Data Plans (VDP), including data quality review and reconciliation sections, ensuring appropriate approvals and TMF filing
- Collaborate with external vendors and sponsors to define study expectations, milestones, timelines, and communication processes
- Ensure external data transfers meet protocol requirements, are in the correct format, and map accurately to systems and subjects
- Develop and validate external data edit checks and reports, including approvals, QC, and UAT activities
- Review discrepancies identified through edit checks and perform query management to resolve data issues
- Maintain documentation of data issues, ensuring proper tracking and resolution through study and vendor logs
- Support protocol and eCRF design reviews from an external data perspective
- Support management of local laboratory data, including QC of lab ranges and verification of subject-level data accuracy
- Plan and support multiple external data management activities simultaneously, providing updates to stakeholders as needed
Requirements
- experience in clinical data environments who enjoys working on technically detailed tasks while collaborating in a cross-functional, global setting. What you can expect from us
- Complete required company and sponsor training and ensure compliance with SOPs, guidelines, and regulatory standards
- University/college degree (Life Sciences, Health Sciences, IT, or related field preferred) or equivalent experience 4+ years of
- experience in clinical trials, pharmaceutical, biotechnology, or related industries
- Experience working with external/vendor data in clinical studies
- Experience supporting multiple projects or workstreams simultaneously
- Strong written and verbal communication skills with ability to engage stakeholders effectively
- Proficiency in Microsoft Office tools and general technical aptitude
- Understanding of ICH-GCP principles Nice to have
- Experience working with central and local laboratory data