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Associate Director, Clinical Data Management
Cabaletta BioAssociate Director leading end-to-end clinical data management for Cabaletta Bio’s autoimmune cellular therapy trials. Overseeing data quality, CROs, regulatory submissions, database locks, and clinical study standards.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in clinical data management, including leadership in global Phase I-IV studies, regulatory compliance, and data integration. Proficient in developing data management plans, overseeing CROs, and ensuring high-quality data delivery.
Highest-signal resume keywords
Clinical Data ManagementRegulatory SubmissionsEDC Design and ImplementationGCP, FDA, ICH ComplianceCRO Oversight
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Data Management PlansDatabase ValidationCRF DesignUAT DocumentationData ReviewMedical CodingData ReconciliationQuery LogicStatistical Analysis PlansCDISC Standards
Soft Skills
LeadershipMentoringProblem-SolvingOrganizational SkillsInterpersonal Skills
Industry Keywords
Clinical ResearchPharmaceuticalBiotechnologyGCPFDAICHMedDRAWHO DrugCDISCSOP Development
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- Competitive benefits
- PTO
- Stock option plans
- Commitment to employee well-being and continuous growth