[Hiring] Associate Director, Clinical Data Management @Cabaletta Bio

Role Description

The Associate Director, Clinical Data Management will serve as a senior Data Management Lead and strategic data management leader across assigned clinical studies. This role will provide 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.

• Serve as senior Data Management Lead for assigned clinical studies across multiple phases, providing end-to-end leadership from 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 review and align stakeholders on quality, timelines, and risk mitigation.
• Oversee CROs and vendors, including selection, performance, quality, timelines, budgets, and change orders.
• Drive study and program milestones, proactively identifying risks and implementing solutions.
• Lead database testing, UAT, data cleaning, coding, reconciliation, database lock, and archival.
• Review data listings and support analyses, safety monitoring committees, endpoint adjudication, and submissions.
• Support regulatory submissions, health authority responses, inspection readiness, and audits.
• Ensure compliance with GCP, applicable FDA and ICH requirements, company procedures, industry standards, and applicable CDISC standards.
• Contribute to data standards, SOPs, technology assessments, and continuous process improvement.
• Provide leadership, mentoring, and technical guidance to data management staff.
• Represent Clinical Data Management on cross-functional teams and communicate status, risks, and resource needs.

Qualifications

• Bachelor's degree in life sciences, health sciences, or a related field.
• 10+ years of progressive clinical data management experience within the pharmaceutical, biotechnology, or clinical research industry.
• Demonstrated experience serving as a senior Data Management Lead and providing end-to-end leadership for global Phase I-IV clinical studies.
• Experience leading clinical data management strategy across multiple studies or development programs.
• Extensive experience overseeing CROs and external vendors, including vendor selection, performance, quality, timelines, budgets, and change orders.
• Demonstrated experience with EDC design and implementation, CRF design, edit checks, query logic, UAT, database validation, data review, and database lock.
• Experience managing external data integrations, data transfers, reconciliation activities, and medical coding processes.
• Working knowledge of MedDRA and WHO Drug dictionaries and coding practices.
• Experience supporting regulatory submissions, health authority responses, inspection readiness activities, and audits.
• Strong knowledge of GCP, FDA, ICH, and other regulatory requirements applicable to clinical data capture and management.
• Working knowledge of CDISC standards, including SDTM and ADaM, and experience collaborating with Biostatistics and Statistical Programming.
• Experience developing and maintaining clinical data management plans, database specifications, validation documentation, CRF completion guidelines, and other study documentation.
• Experience reviewing protocols, statistical analysis plans, CRFs, clinical study reports, and related clinical trial documents.
• Demonstrated ability to lead cross-functional data review, manage complex timelines and risks, and deliver high-quality, analysis-ready clinical data.
• Experience mentoring data management staff and contributing to SOP development, training, technology assessment, and process improvement.
• Outstanding written, verbal, organizational, interpersonal, problem-solving, and leadership skills.

Benefits

• Competitive benefits
• PTO
• Stock option plans