Associate Director, Clinical Data — Data Quality

Precigen, Inc; Germantown (MD); Presencial; USD 170 000 - 185 000; Tempo integral

Resumo da oferta

Precigen, Inc is seeking an Associate Director, Clinical Data in Germantown, MD to lead data management for company-sponsored studies. The role oversees CROs and vendors, ensures data quality from design to lock, and collaborates with study leads and Biostatistics to ensure data is fit for analysis and submission.

The position emphasizes establishing data standards, managing eCRF development, and ensuring regulatory readiness across Phase 3b/4 studies and registries.

Qualificações

• Bachelor's degree in life sciences, health informatics, computer science or related field.

Responsabilidades

• Lead sponsor review and approval of data management plans and related documentation.
• Oversee EDC build, testing, and go-live approval.
• Monitor CRO data management performance against KPIs and data quality.
• Own database lock readiness and sponsor approval to lock.
• Coordinate integration of external data and SAE reconciliation with Safety.
• Drive data standards across the portfolio (CDASH/ CDISC).

Conhecimentos

Data management

Vendor oversight

Regulatory submission experience

Cross-functional collaboration

Attention to detail

Formação académica

Bachelor's degree in life sciences, health informatics, computer science or related field

Ferramentas

Medidata Rave

Veeva CDMS

CDISC CDASH

CDISC SDTM

Descrição da oferta de emprego

Precigen, Inc is seeking an Associate Director, Clinical Data in Germantown, MD to lead data management for company-sponsored studies. The role oversees CROs and vendors, ensures data quality from design to lock, and collaborates with study leads and Biostatistics to ensure data is fit for analysis and submission.

The position emphasizes establishing data standards, managing eCRF development, and ensuring regulatory readiness across Phase 3b/4 studies and registries.