Remote Lead Clinical Data Manager - Medidata Rave

Warman O'Brien; États-Unis; À distance; USD 100 000 - 150 000; Plein temps

Résumé du poste

Warman O'Brien is seeking an experienced Lead Clinical Data Manager to own all CDM activities across the full study lifecycle, from start-up to database lock. You will drive high-quality data through hands-on leadership, cross-functional collaboration and oversight of eCRF design, EDC, edit checks and data reconciliation.

The role requires 5–7+ years in CDM, strong Medidata Rave expertise, and a proven track record of managing studies end-to-end while ensuring regulatory compliance and

Qualifications

• 5–7+ years' experience in Clinical Data Management, including study leadership.
• Strong hands-on expertise with Medidata Rave.
• Proven experience managing studies from start-up through database lock.
• Knowledge of CDISC/SDTM standards, ICH-GCP and FDA/EMA requirements.
• Excellent communication, vendor management and problem-solving skills.
• Ability to work independently in a fast-paced, remote environment.

Responsabilités

• Lead end-to-end Clinical Data Management activities from study start-up through database lock.
• Oversee eCRF design, EDC systems, edit checks, UAT, data cleaning and reconciliation.
• Manage CROs, external vendors and data management deliverables.
• Collaborate with Clinical Operations, Biostatistics, Regulatory and other key stakeholders.
• Ensure data integrity, regulatory compliance and inspection readiness.

Connaissances

Clinical Data Management

Study leadership

Regulatory knowledge

CDISC/SDTM standards

Vendor management

Communication

Independent work

Outils

Medidata Rave

Description du poste

Warman O'Brien is seeking an experienced Lead Clinical Data Manager to own all CDM activities across the full study lifecycle, from start-up to database lock. You will drive high-quality data through hands-on leadership, cross-functional collaboration and oversight of eCRF design, EDC, edit checks and data reconciliation.

The role requires 5–7+ years in CDM, strong Medidata Rave expertise, and a proven track record of managing studies end-to-end while ensuring regulatory compliance and