Remote Principal Specialist, Clinical Data Management

Neurocrine Biosciences; Boston (MA); Hybrid; USD 131,000 - 179,000; Full time

Job summary

Neurocrine Biosciences seeks a Principal Specialist in Clinical Data Management to lead data management activities across studies. You will oversee eCRF design, UAT, database lock, and data quality for regulatory submissions.

Collaborating with Biostatistics, Clinical Operations, and QA, you will ensure CDISC/SDTM compliance and rapid data review in FIH and later programs. Strong programming in SAS/SQL and Medidata Rave experience is required, with leadership responsibilities.

Qualifications

• 8+ years in pharmaceutical data management or CRO
• Hands-on programming in SAS, SQL, and Medidata Rave
• Experience with CDISC standards (SDTM/SDR/CDASH recommended)

Responsibilities

• Lead data management activities for clinical studies and programs
• Design eCRFs, perform UAT, and support database lock
• Ensure CDISC standards and data quality for regulatory submissions
• Coordinate with cross-functional teams and CRO vendors

Skills

SAS

SQL

Medidata Rave Architect

CDISC/SDTM/CDASH

GCP

Data management

Leadership

Communication

Project management

Education

BS/BA in computer science or related

MS in computer science or related

PhD in computer science or related

Tools

Business Objects

Rave

Rave Targeted SDV

Batch Uploader

Job description

Neurocrine Biosciences seeks a Principal Specialist in Clinical Data Management to lead data management activities across studies. You will oversee eCRF design, UAT, database lock, and data quality for regulatory submissions.

Collaborating with Biostatistics, Clinical Operations, and QA, you will ensure CDISC/SDTM compliance and rapid data review in FIH and later programs. Strong programming in SAS/SQL and Medidata Rave experience is required, with leadership responsibilities.