Associate Director, Clinical Data Management

🔥 0 minutes ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

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Cabaletta Bio

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2017

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

Cabaletta Bio is a clinical-stage biotechnology company developing engineered T cell therapies to treat autoimmune diseases. Using its CABA® (Cabaletta Approach to B cell Ablation) platform, the company is advancing rese-cel, a fully human CD19 CAR T cell candidate with a 4-1BB co-stimulatory domain, in multiple RESET™ Phase 1/2 trials for systemic lupus erythematosus, myositis, systemic sclerosis, generalized myasthenia gravis, and pemphigus vulgaris. Cabaletta aims to deliver deep, durable, potentially curative responses by transiently eliminating B cells to reset immune tolerance, and emphasizes patient-centered development and broad indication expansion across rheumatology, dermatology, and neurology.

📋 Description

• Serve as senior Data Management Lead for assigned clinical studies across multiple phases, 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, identify risks, and implement 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, FDA and ICH requirements, company procedures, industry standards, and 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

🎯 Requirements

• Bachelor's degree in life sciences, health sciences, or a related field • 10+ years of progressive clinical data management experience in pharmaceutical, biotechnology, or clinical research • Experience as a senior Data Management Lead 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 selection, performance, quality, timelines, budgets, and change orders • 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, and medical coding • Working knowledge of MedDRA and WHO Drug dictionaries and coding practices • Experience supporting regulatory submissions, health authority responses, inspection readiness, and audits • Strong knowledge of GCP, FDA, ICH, and other applicable regulatory requirements • Working knowledge of CDISC standards, including SDTM and ADaM, and collaboration 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 • 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 • Commitment to employee well-being and continuous growth