Associate Director, Clinical Data Management

About the role

Cabaletta Bio is hiring an Associate Director, Clinical Data Management, based in Philadelphia, PA (remote). The role serves as a senior Data Management Lead and strategic data management leader across assigned clinical studies, providing end-to-end leadership from protocol review and study start-up through database lock, regulatory submission support, long-term follow-up and archival, while ensuring high-quality, analysis-ready clinical data.

Key responsibilities

• Serve as senior Data Management Lead for assigned studies, covering protocol review through database lock, long-term follow-up and archival
• Review protocols and study strategies to ensure feasible, compliant and effective data collection
• Lead EDC, CRF, edit check, query logic, user requirements and CRF completion guideline development
• Oversee external data integrations, transfers, reconciliation, medical coding and validation
• Develop and maintain data management plans, database specifications, validation records, UAT documentation and data review plans
• Lead cross-functional data reviews, align stakeholders on quality, timelines and risk mitigation, and oversee CROs and vendors
• Drive study and program milestones, lead database testing, UAT, data cleaning, coding, reconciliation, database lock and archival
• Support regulatory submissions, health authority responses, inspection readiness and audits, and ensure compliance with GCP, FDA, ICH and CDISC standards
• Mentor data management staff, contribute to SOPs and process improvement, and represent Clinical Data Management on cross-functional teams

Required profile

• Bachelor's degree in life sciences, health sciences or a related field
• 10+ years of progressive clinical data management experience in pharma, biotech or clinical research
• Demonstrated experience as a senior Data Management Lead for global Phase I-IV studies and leading strategy across multiple studies or programs
• Extensive experience overseeing CROs and external vendors, including selection, performance, quality, timelines, budgets and change orders
• Experience supporting regulatory submissions, health authority responses, inspection readiness and audits
• Experience mentoring staff, developing SOPs and driving process improvement

Required skills

• EDC design and implementation, CRF design, edit checks, query logic, UAT, database validation and lock
• External data integration, transfer, reconciliation and medical coding
• Working knowledge of MedDRA and WHO Drug dictionaries
• Strong knowledge of GCP, FDA, ICH and CDISC (SDTM, ADaM)
• Experience collaborating with Biostatistics and Statistical Programming

What we offer

• Health and retirement benefits
• PTO
• Stock option plans