Lead Clinical Data Manager

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

We are 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 an excellent opportunity for experienced Clinical Data Management professionals who enjoy taking ownership of studies, working autonomously and collaborating closely with cross-functional teams and external vendors.

The successful candidates will play a key role in overseeing clinical data management activities, ensuring high-quality data delivery, regulatory compliance and inspection readiness from study start-up through database lock and submission.

Key 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.

Requirements

• 5–7+ years of Clinical Data Management experience, including responsibility for leading clinical studies.
• Strong experience managing clinical data from study start-up through database lock.
• Strong Medidata Rave expertise, with certification considered advantageous.
• Hands‑on experience with EDC systems, UAT, data review, query management and reconciliation.
• Experience overseeing CROs, external vendors and cross-functional study teams.
• Good understanding of CDISC/SDTM standards, ICH-GCP and 21 CFR Part 11.
• Strong communication, organisational and stakeholder management skills.
• Ability to work independently, manage competing priorities and take ownership of study deliverables.

Why Consider This Opportunity?

• Fully remote working arrangement.
• Opportunity to take ownership of clinical data management activities across the study lifecycle.
• Significant interaction with cross-functional teams and external partners.
• A role suited to proactive, hands‑on Data Managers who enjoy both technical delivery and study leadership.