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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