Remote Clinical Data Management Study Lead

Regulatory Jobs; United States; Remote; USD 115,000 - 187,000; Full time

Job summary

Regeneron is seeking a ManagerCDM to oversee lead Data Managers on assigned clinical data management studies, ensuring data deliverables meet Regeneron standards and timelines. You will contribute to SOPs, Working Practice, Data Management Plans, and other data management standards.

The role requires at least 7 years in clinical data management, with strong leadership and CRO collaboration. Remote work is available with some travel as needed.

Qualifications

• Bachelor degree or equivalent in math/science with 7+ years clinical data management experience.
• Lead data management deliverables and ensure SOPs and standards are followed.
• Provide CRO/vendor liaison on eCRF design, data quality and reporting.
• Oversee data quality reviews and data acceptance prior to analyses and lock.
• Identify risks and escalate issues for resolution.

Responsibilities

• Serve as the DM study lead and primary contact for study teams and CROs.
• Provide high level data management expertise to support clinical studies.
• Communicate clearly to project teams and CROs on data design and quality.
• Ensure electronic case report forms, CTD and edit checks meet SOPs/WIs.
• Escalate issues and monitor data quality throughout studies.

Skills

Data management leadership

eCRF design

Database design

CRO liaison

Data quality

SOP development

Education

Bachelor's degree or equivalent in Mathematics, Science or related field

Job description

Regeneron is seeking a ManagerCDM to oversee lead Data Managers on assigned clinical data management studies, ensuring data deliverables meet Regeneron standards and timelines. You will contribute to SOPs, Working Practice, Data Management Plans, and other data management standards.

The role requires at least 7 years in clinical data management, with strong leadership and CRO collaboration. Remote work is available with some travel as needed.