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Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Lead DTS Development: Author and manage Data Transfer Specifications (DTS) to align external data providers and research partners on required data structures, formats, and templates.
- Oversee Data Standardization: Ensure study teams adhere to CDISC standards for external data, including biomarkers, wearable devices, IRT, imaging, and eCOA.
- Cross-Functional Collaboration: Serve as the primary contact for external data quality control, participating as an extended member of the Clinical Study Team and facilitating new test codes.
- Vendor & Process Management: Provide operational oversight to external data vendors, manage change requests for existing DTS, and contribute to continuous process improvement initiatives.
- Data Reconciliation & Compliance: Support data reconciliation, resolve structure inquiries, and comply with all regulatory requirements, including clinical protocols and analysis expectations.
Requirements
What you’ll need- Minimum of 8 years of external clinical data management or programming experience within the biotechnology, pharmaceutical, or health-related industry
- Bachelor’s degree in Biology, Computer Science, Programming, Data Management, or a related scientific/analytic discipline
- Advanced knowledge of extracting data into SAS, CSV, and XML formats
- Strong understanding of database structures
- Deep understanding of data management processes, industry best practices, and applicable regulations including 21 CFR Part 11, ICH-GCP Guidelines, and CDISC standards
- Proven experience managing multiple clinical data types (eCOA, imaging, and external data), with preferred expertise in biomarker and imaging data for oncology and non-oncology studies.
Benefits
Comp & perks- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Data Transfer SpecificationsSASCSVXMLdata managementdata reconciliationdatabase structuresclinical data typesbiomarker dataimaging data
Soft Skills
cross-functional collaborationoperational oversightprocess improvementcommunication