Remote Senior Director, Clinical Data Management

Cabaletta Bio; All (MO); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Stock options

Competitive benefits

PTO

Job summary

Cabaletta Bio is seeking an Associate Director, Clinical Data Management (Remote) to lead data management across global studies from protocol review to database lock and submission support. This senior role requires strategic leadership, cross-functional collaboration, and a strong command of regulatory standards.

The position emphasizes end-to-end data management, CRO/vendor oversight, and proactive risk mitigation to ensure high-quality, analysis-ready data for regulatory submissions.

Qualifications

• Bachelor’s degree in life sciences, health sciences, or a related field.
• 8+ years of progressive clinical data management experience in pharma/biotech/clinical research.
• Experience as a senior Data Management Lead on global Phase I–IV studies.
• Experience leading data management strategy across multiple studies or programs.
• Extensive experience overseeing CROs and external vendors, including budgets and change orders.
• Experience with EDC design and implementation, CRF design, edit checks, query logic, UAT, database validation, data review, and database lock.
• 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 CDISC SDTM/ADaM; collaboration with Biostatistics/STAT.
• Experience developing and maintaining data management plans, specifications, validation docs, and study documentation.
• Experience reviewing protocols, SAPs, CRFs, CSRs, and related trial documents.
• Ability to lead cross-functional data reviews, manage timelines/risks, and deliver analysis-ready data.
• Mentoring data management staff and contributing to SOPs and process improvements.
• Excellent written, verbal, organizational, interpersonal, and leadership skills.

Responsibilities

• Serve as senior Data Management Lead for assigned studies across multiple phases, providing end-to-end leadership.
• Review protocols and study strategies to ensure compliant data collection.
• Lead EDC, CRF design, edit checks, query logic, and UAT guideline development.
• Oversee external data integrations, transfers, reconciliation, medical coding, and validation.
• Develop and maintain data management plans, 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, timelines, budgets, and change orders.
• Drive study milestones and proactively 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/ICH, company procedures, and CDISC standards (SDTM/ADaM).
• Contribute to data standards, SOPs, and continuous process improvement.
• Provide leadership, mentoring, and technical guidance to staff.
• Represent CDM on cross-functional teams and communicate status, risks, and resource needs.

Skills

Leadership

Cross-functional collaboration

Regulatory knowledge

Problem solving

Mentoring

Education

Bachelor's degree in life sciences/health sciences

Tools

EDC design

CRF design

Edit checks

Query logic

UAT

Database validation

Data review

Database lock

Job description

Cabaletta Bio is seeking an Associate Director, Clinical Data Management (Remote) to lead data management across global studies from protocol review to database lock and submission support. This senior role requires strategic leadership, cross-functional collaboration, and a strong command of regulatory standards.

The position emphasizes end-to-end data management, CRO/vendor oversight, and proactive risk mitigation to ensure high-quality, analysis-ready data for regulatory submissions.