Remote Lead Clinical Data Manager: End-to-End Ownership

Warman O'Brien; United States; Remote; USD 120,000 - 160,000; Full time

Job summary

Warman O'Brien is partnering with a leading life sciences organisation to recruit multiple Lead Clinical Data Managers to support clinical trials across the full study lifecycle. This is a senior, autonomous role overseeing data management activities and collaborating with cross-functional teams and external vendors.

The successful candidates will ensure high-quality data delivery, regulatory compliance and inspection readiness from study start-up through database lock and submission, with a

Qualifications

• 5–7+ years of Clinical Data Management experience with lead responsibilities
• Experience managing data from study start-up through database lock
• Hands-on Medidata Rave expertise; certification advantageous
• Experience overseeing CROs and external vendors and cross-functional study teams
• Knowledge of CDISC/SDTM, ICH-GCP and 21 CFR Part 11
• Strong communication, organisational and stakeholder management skills
• Ability to work independently and manage competing priorities

Responsibilities

• Lead end-to-end Clinical Data Management activities from protocol development and study start-up through database lock, submission and archival
• Act as the primary sponsor-side Data Management contact, collaborating with CROs, vendors and internal stakeholders
• Oversee eCRF design, EDC setup, edit checks, UAT, data validation and query management
• Develop and maintain Data Management Plans (DMPs), data handling procedures and study documentation
• Manage external vendors, data transfers, integrations and reconciliation activities to ensure timely, high-quality deliverables
• Partner with Clinical Operations, Biostatistics, Clinical Science, Safety and Regulatory Affairs teams
• Maintain inspection readiness and ensure compliance with ICH-GCP, FDA/EMA requirements and applicable data standards
• Identify opportunities to improve data management processes, quality and operational efficiency

Skills

Clinical Data Management

CDISC/SDTM

ICH-GCP & 21 CFR Part 11

Data quality & validation

Stakeholder management

Independent work

Study leadership

Tools

Medidata Rave

EDC systems

UAT

Data reconciliation

Query management

Job description

Warman O'Brien is partnering with a leading life sciences organisation to recruit multiple Lead Clinical Data Managers to support clinical trials across the full study lifecycle. This is a senior, autonomous role overseeing data management activities and collaborating with cross-functional teams and external vendors.

The successful candidates will ensure high-quality data delivery, regulatory compliance and inspection readiness from study start-up through database lock and submission, with a