Remote Clinical Data Manager: Data Quality & CDISC Lead

Pharmavise Corporation; United States; Teletrabalho; USD 90 000 - 130 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Paid holidays

PTO (Paid Time Off)

Medical insurance

Resumo da oferta

Pharmavise Consulting Corporation is seeking a Clinical Data Manager for a remote role in the United States. You will oversee data integrity from collection through database lock, ensuring accuracy, consistency, and regulatory compliance across cross‑functional teams.

Responsibilities include CRF/EDC design, DMP development, data validation, and coordination with vendors. The ideal candidate has 3–5 years in CDM and strong knowledge of ICH‑GCP and CDISC standards.

Qualificações

• Bachelor's degree in Life Sciences or related field.
• 3–5 years in clinical data management in pharma/biotech/CRO.
• Proficiency in EDC platforms (Medidata Rave, Oracle InForm, Veeva, REDCap).
• Understanding of ICH-GCP, FDA, and CDISC standards.
• Strong organizational and communication skills.

Responsabilidades

• Design and review CRFs and EDC systems to ensure accurate data capture.
• Develop and maintain data management plans (DMPs) and data validation specs.
• Oversee data cleaning and data queries with study teams.
• Perform ongoing data reviews to identify trends and deviations.
• Ensure adherence to CDISC standards and regulatory requirements.
• Manage database lock activities and CSR preparation.

Conhecimentos

Clinical data management

Data quality assurance

Regulatory knowledge

Cross-functional collaboration

Formação académica

Bachelor's degree in Life Sciences or related field

Advanced degree a plus

Ferramentas

Medidata Rave

Oracle InForm

Veeva

REDCap

Descrição da oferta de emprego

Pharmavise Consulting Corporation is seeking a Clinical Data Manager for a remote role in the United States. You will oversee data integrity from collection through database lock, ensuring accuracy, consistency, and regulatory compliance across cross‑functional teams.

Responsibilities include CRF/EDC design, DMP development, data validation, and coordination with vendors. The ideal candidate has 3–5 years in CDM and strong knowledge of ICH‑GCP and CDISC standards.