Senior Director, Data Management

DBV Technologies; Virginia; Sur place; USD 200 000 - 280 000; Plein temps

Résumé du poste

DBV Technologies in Warren, New Jersey, seeks a Senior Director of Data Management to lead clinical data management, bringing SDTM/CDISC standards in-house and overseeing EDC build with a focus on data quality and regulatory compliance.

You will manage CRO partners, build an internal team, and own a data management function that is evolving to meet global development needs.

Qualifications

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

Responsabilités

• 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.

Connaissances

Data management leadership

Regulatory knowledge

Cross-functional collaboration

SDTM/ADaM knowledge

Statistical data analysis

Formation

Master's degree in life sciences or equivalent

Outils

Medidata Rave

SAS

R

Python

JMP Live

Description du poste

Description :

The Senior Director, Data Management will lead clinical data management at DBV Technologies, a biopharmaceutical company developing treatments for food allergy. The role is responsible for moving core data collection and standards work, including EDC build and SDTM configuration, from external vendors to an internal team, while keeping data quality and regulatory requirements intact. You will work with Clinical, Biostatistics, Safety, and Regulatory colleagues, direct the data management work of our CRO partners, and build out the internal team. The position suits someone with deep hands-on data management experience who wants broad ownership of a function that is still taking shape.

Location :Warren, New Jersey - minimum 3 days on site

Salary Range :$200-280k

Key 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.

Qualifications :

• Mastery of global Data Management processes.

• Strong experience with Electronic Data Capture (EDC) systems, particularly Medidata Rave.

• Experience with ePRO (electronic Patient Reported Outcomes) solutions

• Advanced knowledge of CDISC SDTM and ADaM data standards.

• Proficiency in SAS programming language; experience with JMP, JMP Live, R, Python, or other data science tools is highly desirable.

• Behavioral skills :

• Curiosity: Keep on exploring uncharted territories. Always ask “why?” and more importantly “why not?”,

• Courage: Take smart risks, mentor each other to always do better & be accountable for our choices, our opinions, and our actions,

• Collaboration: Teamwork and spirit. Support each other and be equally involved in the achievement of our common goals,

• Credibility: Be transparent, follow through and build trust. Educate ourselves about our unique technology.