Remote Senior Clinical Data Manager - Lead & Own Projects

Warman O'Brien

Milton Keynes

Remote

GBP 65,000 - 90,000

Full time

10 days ago
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Job summary

Leading Global CRO is seeking a Senior Clinical Data Manager to own data management deliverables on UK-based remote projects. You will lead study builds, drive data quality, and coordinate with QA during audits.

The role emphasizes team leadership, training, regulatory knowledge (ICH-GCP), and effective client communication. You will develop and maintain key documents such as the DMP and DQRP, manage timelines, and ensure data integrity for regulatory submissions.

Qualifications

  • Bachelor’s or Master’s degree in health/pharmaceutical sciences, physical/biological sciences, or chemistry fields.
  • 5+ years in pharmaceutical clinical trial data management (or 2+ years as CDM II).
  • Strong knowledge of ICH-GCP, data standards, and dataflows.
  • Proven leadership in CDM activities and complex projects.

Responsibilities

  • Study Build & Design: Lead eCRF design, annotated CRFs, and participate in UAT.
  • Data Strategy Documentation: Develop and maintain DMP, Data Management Project Plan, and DQRP.
  • Data Cleaning & Harmonisation: Oversee data review, query resolution, SAE reconciliation, and third-party data streams.
  • Lock & Archive: Manage post-go-live modifications, locks, and QA coordination.

Skills

CDM leadership
Project ownership
Client relationship management
Regulatory knowledge (ICH-GCP)
Data management processes
Training & mentoring

Education

Bachelor’s or Master’s degree in health/pharmaceutical sciences or chemistry

Tools

EDC systems
Data management tools

Job description

Leading Global CRO is seeking a Senior Clinical Data Manager to own data management deliverables on UK-based remote projects. You will lead study builds, drive data quality, and coordinate with QA during audits.

The role emphasizes team leadership, training, regulatory knowledge (ICH-GCP), and effective client communication. You will develop and maintain key documents such as the DMP and DQRP, manage timelines, and ensure data integrity for regulatory submissions.

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