Remote Senior Clinical Data Manager & Study Lead

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

Benefits offered by this job

Annual bonuses

Equity awards

Pension or retirement benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits (medical, dental, V

Paid time off

Family support benefits

Job summary

Regeneron is seeking a Manager Clinical Data Manager Study Lead to oversee lead data managers on assigned studies, ensuring data management deliverables meet Regeneron standards and timelines. You will support SOP development, Data Management Plans, and related standards across therapeutic areas.

You will coordinate with study teams and external partners, drive data quality, oversee EC/EDC design and data transfer activities, and manage archiving and study close-out with a focus on process

Qualifications

• Bachelor Degree or equivalent experience in Mathematics, Science or a related field.
• At least 7 years of clinical data management experience in biotechnology, pharmaceutical or health-related industry.
• Ability to lead data management deliverables across multiple studies and interact with CROs and vendors.

Responsibilities

• Oversee DM activities across all stages of the trial from start-up through archiving.
• Provide expertise in data management to support clinical studies.
• Coordinate with project teams and CROs on eCRF, database design, data quality and reporting.
• Oversee data quality reviews, data acceptance and database lock processes.
• Manage data transfers with CROs and third-party data sources; SAE/AE reconciliation and coding.
• Develop recommendations for improved data management processes.
• Ensure SOPs and work instructions for DM are followed and maintained.

Skills

Data management

Vendor management

Study leadership

Documentation

Education

Bachelor degree or equivalent in Mathematics, Science or related field

Tools

eCRF design

EDC systems

Database design

Job description

Regeneron is seeking a Manager Clinical Data Manager Study Lead to oversee lead data managers on assigned studies, ensuring data management deliverables meet Regeneron standards and timelines. You will support SOP development, Data Management Plans, and related standards across therapeutic areas.

You will coordinate with study teams and external partners, drive data quality, oversee EC/EDC design and data transfer activities, and manage archiving and study close-out with a focus on process