Clinical Data Manager

Warman O'Brien; United States; Remote; USD 130,000 - 190,000; Full time

Job summary

Warman O'Brien is seeking an experienced Lead Clinical Data Manager to own clinical data management activities across the full study lifecycle, from start-up through database lock. This hands-on leader will drive high‑quality data delivery for complex studies and collaborate with cross-functional teams.

The role requires 5–7+ years in CDM, strong Medidata Rave skills, and proven experience overseeing studies from start-up to database lock in a remote environment in the United States.

Qualifications

• 5–7+ years in Clinical Data Management with study leadership.
• 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.

Responsibilities

• 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.

Skills

CDM leadership

Medidata Rave

Vendor management

CDISC/SDTM

ICH-GCP

Data integrity

Communication

Independent work

Job description

We're looking for an experienced Lead Clinical Data Manager to take ownership of clinical data management activities across the full study lifecycle, from start-up through database lock.

This is a fantastic opportunity for a proactive, hands‑on professional to lead complex clinical studies, collaborate with cross-functional teams and drive high‑quality data delivery.

Key Responsibilities

• 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.

What We're Looking For

• 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.