Clinical Data Management Lead – Strategy & Study Delivery

Neurocrine Continental; San Diego (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Neurocrine Biosciences is seeking a Clinical Data Management Lead to oversee staff and data management activities across one or more clinical programs. You will design, development, implementation, and validation of clinical study databases, maintain data management standards, and contribute to strategic planning within Biometrics.

You will lead DM staff, oversee budgets, coordinate with CROs, and ensure GxP compliance, while driving continuous improvement in data capture, validation, and

Qualifications

• Lead data management activities for clinical studies and ensure DM tasks are completed.
• Hire, train, and supervise CDM staff and CRO data programmers.
• Oversee budgeting, timelines, and vendor management for DM programs.
• Ensure GxP compliance and implement standardized DM documents and processes.

Responsibilities

• Lead data management activities and ensure DM tasks are completed for studies.
• Hire, train, mentor, and evaluate CDM staff and programmers.
• Assess software/tool needs for data management.
• Manage DM budgets and timelines to meet goals.
• Represent DM on cross-functional committees for improved processes and GxP compliance.
• Provide DM leadership and act as a technical resource within Biometrics.
• Ensure DM standards are implemented and up-to-date.
• Research industry trends and propose DM improvements.
• Participate in vendor/CRO selection; review proposals and budgets.
• Develop and maintain standardized DM documents (eCRFs, edit checks).
• Provide DM leadership at subteam and study meetings with risk planning.
• Identify risks and communicate solutions to management.
• Manage in-house and CRO resources; resolve timeline issues.
• Lead CDM on studies; hands-on tasks (protocol review, eCRFs, UAT).
• Lead NDA submissions as appropriate.
• Respond to QA audits.

Skills

Leadership

Data management

Staff management

Budget management

Vendor management

GxP compliance

SAS

eCRF design

UAT

Cross-functional collaboration

Tools

SAS

EDC systems

Job description

Neurocrine Biosciences is seeking a Clinical Data Management Lead to oversee staff and data management activities across one or more clinical programs. You will design, development, implementation, and validation of clinical study databases, maintain data management standards, and contribute to strategic planning within Biometrics.

You will lead DM staff, oversee budgets, coordinate with CROs, and ensure GxP compliance, while driving continuous improvement in data capture, validation, and