Senior Clinical Data Manager

Pop Science; City Of London; On-site; GBP 60,000 - 85,000; Full time

Job summary

A leading clinical research organization is seeking a Senior Clinical Data Manager to oversee the end-to-end Data Management lifecycle for clinical trials. This role involves ensuring data quality and regulatory compliance, mentoring team members, and managing vendors. Ideal candidates have strong experience in clinical data management and expertise in EDC systems and CDISC standards.

Qualifications

• Strong experience in Clinical Data Management on complex/global studies.
• Expertise in EDC systems and regulatory compliance.
• Ability to mentor team members and manage quality.

Responsibilities

• Lead database design and data management plans.
• Oversee data review, queries, and quality checks.
• Deliver clean, submission-ready datasets.

Skills

Strong experience running studies

Expert knowledge of EDC systems

Strong understanding of ICH-GCP

Experience mentoring or guiding team members

Proven ability to manage vendors

Tools

EDC systems

CDISC standards

Job description

We have a great role for a Senior Clinical Data Manager working for a client.

As a Senior Clinical Data Manager, you will lead the end-to-end Data Management lifecycle for complex or pivotal clinical trials. You'll own data quality, standards, compliance, and delivery-from database design through to database lock and submission-acting as the senior point of accountability across programs.

You will drive best practice, guide cross-functional alignment, and ensure that high-quality, regulatory-ready data underpins critical clinical and regulatory decisions.

Key Responsibilities

Startup & Planning

• Lead database design, CRF development, edit checks and data flow planning
• Develop Data Management Plans, validation specs and standards
• Ensure consistent application of CDISC and controlled terminology

Execution & Quality Oversight

• Oversee data review, queries, coding, reconciliation and quality checks
• Act as the primary DM contact for Clinical, Biometrics and vendors
• Identify risks early and implement process improvements
• Support interim analyses, safety reviews and IDMC/DSMB data needs

Closeout & Submission

• Lead database lock, ensuring all data are complete, reconciled and audit-ready
• Deliver clean, submission-ready datasets and documentation
• Ensure full compliance with GCP/ICH and 21 CFR Part 11

What You Bring

• Strong experience running studies in Clinical Data Management on complex/global studies
• Expert knowledge of EDC systems, CDISC standards and coding dictionaries
• Strong understanding of ICH-GCP, 21 CFR Part 11 and regulatory requirements
• Experience mentoring or guiding team members
• Proven ability to manage vendors, timelines and quality in fast-paced environments

Who You Are

• Strategic thinker with strong attention to detail
• Skilled communicator and natural cross-functional collaborator

Contact David Atkin for more information

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