Position Overview:

We are seeking a motivated and experienced Clinical Data Management professional to serve as the sponsor-side data management lead for assigned clinical studies within our growing development portfolio.

Reporting to the Senior Director of Data Management, this role is responsible for driving study-level data management activities from study start-up through database lock while ensuring high-quality, inspection-ready clinical data. The Manager/Senior Manager will work closely with Clinical Operations, Biostatistics, Statistical Programming, Medical, Regulatory, and external partners to support the successful execution of clinical trials.

This role is ideal for an experienced clinical data manager who enjoys hands-on study ownership, cross-functional collaboration, and helping advance innovative therapies in a fast-paced biotechnology environment.

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.