Senior Clinical Data Manager

No 3rd party candidates

• Review protocols from a CDM perspective and provide functional-expert feedback
• Review and approve key clinical data management deliverables generated by a DM vendor
• Manage / oversee study setup, testing and system validation for new studies in partnership with the DM vendor
• Oversee data cleaning activities executed by the DM vendor and ensures protocol-specified guidelines are applied to the review and cleaning of clinical data
• Develop and manage timelines for key clinical data management deliverables in coordination with the clinical data management vendor and project team
• Monitor vendor performance to ensure timelines and data quality standards are met
• Requirements
• Bachelor's degree in mathematics, science, or a health-related field and 10+ years of clinical data management experience in biotech, pharmaceutical, or health-related industries
• Demonstrated proficiency leading CDM deliverables across Phase 1–3 clinical trials, including early-phase and dose-escalation studies
• Solid understanding of the clinical drug development process and regulatory/data standards
• Demonstrated understanding of the clinical trial database life cycle, including CRF design, development/testing, discrepancy management, data quality review, and database lock
• Capable of proactively identifying project risks and proposing strategic solutions; excellent multi-disciplinary interpersonal and communication skills