Remote Associate Director, Clinical Data Management

Cabaletta Bio; Philadelphia (Philadelphia County); On-site; USD 130,000 - 180,000; Full time

Benefits offered by this job

Health benefits

Retirement plan

Paid time off (PTO)

Stock option plan

Job summary

Cabaletta Bio is seeking an Associate Director, Clinical Data Management in Philadelphia. The role leads data management across studies, overseeing EDC/CRF design, data validation, and external data transfers to ensure high-quality, analysis-ready data.

The position requires a track record of senior DM leadership for global Phase I–IV trials, strong regulatory submission experience, and deep knowledge of GCP, FDA/ICH and CDISC standards. A hybrid work setup with remote flexibility is available.

Qualifications

• Bachelor's degree in life sciences, health sciences, or a related field.
• 10+ years of progressive clinical data management experience in pharma/biotech/clinical research.
• Demonstrated experience as a senior Data Management Lead with end-to-end leadership for global Phase I-IV studies.
• Experience leading data management strategy across multiple studies or programs.
• Extensive experience overseeing CROs and external vendors, incl. vendor selection, performance, budgets.
• Experience with EDC design/implementation, CRF design, edit checks, UAT, and database validation.
• Working knowledge of MedDRA and WHO Drug dictionaries and coding practices.
• Experience supporting regulatory submissions and inspections, with GCP/FDA/ICH knowledge.
• CDISC SDTM/ADaM knowledge; collaboration with Biostatistics/Statistical Programming.

Responsibilities

• Serve as senior Data Management Lead across assigned studies, guiding end-to-end data lifecycle.
• Review study protocols to ensure feasible, compliant data collection.
• Lead EDC/CRF design, edit checks, and data quality guidelines.
• Oversee external data transfers, validation, and medical coding processes.
• Develop DM plans, database specifications, and UAT documentation.
• Coordinate cross-functional data reviews, timelines, and risk management.
• Manage CROs/vendors, budgets, timelines, and change orders.
• Support regulatory submissions and health authority responses.
• Ensure adherence to GCP, FDA/ICH, and CDISC standards.
• Mentor DM staff and contribute to SOPs and process improvements.

Skills

Strategic leadership

End-to-end data management

Cross-functional collaboration

Vendor/CRO oversight

Regulatory submissions support

MedDRA/WHO-Dictionaries knowledge

GCP/FDA/ICH knowledge

Mentoring staff

Education

Bachelor's degree in life sciences/health sciences or related field

Tools

EDC design/implementation

CRF design

UAT lifecycle

Database validation

Data integration

Medical coding (MedDRA/WHO)

Job description

Cabaletta Bio is seeking an Associate Director, Clinical Data Management in Philadelphia. The role leads data management across studies, overseeing EDC/CRF design, data validation, and external data transfers to ensure high-quality, analysis-ready data.

The position requires a track record of senior DM leadership for global Phase I–IV trials, strong regulatory submission experience, and deep knowledge of GCP, FDA/ICH and CDISC standards. A hybrid work setup with remote flexibility is available.