Senior Director, Data Management & SDTM Lead

DBV Technologies; Bernards Township (NJ); On-site; USD 200,000 - 280,000; Full time

Job summary

DBV Technologies seeks a Senior Director, Data Management to lead clinical data management and move core data collection and standards work in-house while upholding data quality and regulatory compliance.

You will oversee EDC build and SDTM configuration, work with Clinical, Biostatistics, Safety, and Regulatory teams, and direct CRO partners. The role requires deep hands-on data management experience and broad ownership as the function evolves.

Qualifications

• Mastery of global Data Management processes.
• Strong experience with Electronic Data Capture (EDC) systems, particularly Medidata Rave.
• Experience with ePRO solutions.
• Advanced knowledge of CDISC SDTM and ADaM data standards.
• Proficiency in SAS; experience with JMP, JMP Live, R, Python, or other data science tools is highly desirable.

Responsibilities

• Provide senior oversight of data management processes from CRF development to SDTM programming.
• Standardize study monitoring reports and data management metrics directly from EDC.
• Support integration and management of pharmacovigilance data streams for signal detection, regulatory, and analytical needs.
• Global CRO oversight of data management activities and delegation of tasks to internal team.
• Management of database lifecycle activities, including freeze, lock, and archiving and support team as backup for existing studies and support and development of data pipelines for prospective studies.

Skills

Data leadership

Clinical data management

Regulatory knowledge

Education

Master's degree in bio/pharma/related field

Tools

Medidata Rave

SAS

JMP

R

Python

Job description

DBV Technologies seeks a Senior Director, Data Management to lead clinical data management and move core data collection and standards work in-house while upholding data quality and regulatory compliance.

You will oversee EDC build and SDTM configuration, work with Clinical, Biostatistics, Safety, and Regulatory teams, and direct CRO partners. The role requires deep hands-on data management experience and broad ownership as the function evolves.