Manager/Senior Manager, Clinical Data Management

Primary Responsibilities

• Lead Study-Level Data Management Activities
• Serve as the sponsor-side Clinical Data Management lead for assigned clinical studies.
• Manage clinical data management activities from study start-up through database lock and archival.
• Ensure clinical data are complete, accurate, and fit-for-purpose to support study objectives, interim analyses, clinical study reports, and regulatory submissions.
• Track and communicate study-level data management metrics, risks, and timelines.
• Drive issue resolution and proactively identify opportunities to improve data quality and operational efficiency.
• CRO and Vendor Oversight
• Serve as the primary data management contact for CROs and external vendors supporting assigned studies.
• Oversee outsourced data management activities to ensure quality expectations and timelines are met.
• Review deliverables and provide feedback on data management plans, CRF completion guidelines, edit checks, reconciliation plans, and data transfer specifications.
• Support oversight of external data sources including central laboratories and specialty vendors.
• Escalate risks, quality concerns, and timeline impacts with recommended mitigation strategies.
• Database and Data Quality Management
• Lead cross-functional review activities for CRF design and database development and ensure adherence to Beam and/or CDASH/CDISC standards.
• Review edit check specifications and coordinate user acceptance testing activities.
• Support development and review of Data Management Plans and other study-level documentation.
• Ensure appropriate reconciliation activities are conducted, including SAE and external vendor reconciliations.
• Monitor data cleaning activities and partner with CROs to drive timely query resolution and database readiness.
• Inspection Readiness and Cross-Functional Partnership
• Maintain inspection-ready documentation throughout the study lifecycle.
• Support internal audits, sponsor inspections, and regulatory inspection readiness activities.
• Collaborate closely with Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, Regulatory Affairs, and Quality.
• Communicate complex data issues clearly and effectively to study teams and leadership.

Qualifications

• BS or MS degree in a scientific, health-related, or technical discipline.
• 5+ years of clinical data management experience within biotechnology, pharmaceutical, or CRO environments.
• Experience supporting Phase I–III clinical trials from study start-up through database lock.
• Working knowledge of CDASH/CDISC standards, GCP/ICH requirements, and applicable regulatory expectations.
• Strong hands-on experience with EDC systems (e.g., Medidata RAVE, Veeva EDC, Oracle Inform).
• Experience managing CROs and external data vendors.
• Familiarity with SDTM concepts and clinical data review processes.
• Experience with data visualization or reporting tools such as J-Review or similar platforms.
• Strong analytical, organizational, and problem-solving skills.
• Ability to manage multiple priorities and meet timelines in a fast-paced environment.
• Excellent written and verbal communication skills.

Preferred Qualifications

• Experience supporting late-stage or registrational clinical studies.
• Experience in gene editing, cell therapy, rare disease, or other complex development programs.