Job Description

Job Description

Position Summary

The Lead Clinical Data Manager will provide hands-on oversight of clinical data management activities for one or more clinical trials across our client’s oncology development programs. This role is responsible for external CRO management and any in-house DM activities as needed, ensuring the accuracy, integrity, and timeliness of clinical trial data from study start-up through database lock, and will be working closely with internal cross-functional teams.

This position serves as the primary data management point of contact at the study level.

Key Responsibilities

• Lead and oversee end-to-end clinical data management activities for assigned clinical trials, including study start-up, conduct, and close-out.
• Provide CRO oversight, ensuring performance, quality, timelines, and contractual deliverables are met.
• Develop, review, and maintain key data management deliverables, including:
• Data Management Plans (DMPs)
• eCRF design and completion guidelines
• Edit check and data validation specifications
• External data transfer and reconciliation plans
• Provide oversight of EDC database design, build, validation, and User Acceptance Testing (UAT).
• Oversee ongoing data review, discrepancy management, coding activities, and reconciliation of external data sources (e.g., labs, ECG, imaging).
• Collaborate closely with Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, and Safety to ensure integrated data delivery and readiness for interim analyses, database lock, and regulatory submissions.
• Support database lock activities and ensure inspection-ready documentation and processes.
• Identify data-related risks and proactively implement mitigation strategies to ensure data quality and compliance.
• Contribute to the development and maintenance of data management SOPs, processes, and best practices.

Qualifications

• 10+ years of clinical data management experience in a pharmaceutical or biotechnology setting and bachelor’s degree
• Demonstrated experience leading data management activities for clinical trials from study start-up through database lock.
• Prior experience in oncology clinical trials.
• Hands-on experience with EDC systems.
• Experience managing CROs and external vendors in a sponsor environment.

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