Senior CDM & Study Lead — Remote

Regeneron Pharmaceuticals, Inc (USA); Village of Tarrytown (NY); Remote; USD 173,000 - 187,000; Full time

Benefits offered by this job

Annual bonuses or incentive plans

Equity awards

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits (medical, dental, 1

Paid time off

Family support benefits

Job summary

Regeneron Pharmaceuticals, Inc. seeks a Manager, Clinical Data Management (CDM), Study Lead to support clinical study teams and external partners on small or noncomplex studies or larger studies within a therapeutic area.

Coordinate all DM activities from study start-up to archiving, provide expertise in data management, support eCRF and database design, and ensure data quality. The role performs data quality reviews, data acceptance, and coordinates data transfers with CROs; maintains eTMF

Qualifications

• Requires a Bachelor’s degree in Mathematics, Pharmaceutical Science, Pharmaceutics or related field and 6 years of clinical data management experience.
• Experience with applying regulations (21 CFR Part 11, ICH GCP) and CDISC standards to clinical data collection and management.
• Experience coordinating clinical studies and study teams within a regulated data processing environment.
• Experience applying data management processes across the lifecycle and improving workflows.
• Experience resolving complex data issues by analyzing requirements and implementing compliant solutions.
• Experience delivering written documentation and verbal communications for crossfunctional study teams.

Responsibilities

• Coordinate all DM activities from study start-up to archiving.
• Provide expertise in data management, support eCRF and database design, and ensure data quality.
• Perform data quality review procedures, data acceptance, and coordinate data transfers with CROs.
• Document and support CRO data management activities, ensuring adherence to SOPs and identifying data quality issues.
• Review and approve study documentation, including DMP, CRF, and validation specifications.
• Maintain eTMF documentation and perform quality reviews to ensure inspection readiness.
• Responsible for data management deliverables, ensuring timelines align with business needs and objectives.
• Monitor data quality, assess data issue progress, and propose risk mitigations.
• May act as a Subject Matter Expert (SME) for specific topics and provide training.
• Represent DM in study-level forums and meetings.

Education

Bachelor’s degree in Mathematics, Pharmaceutical Science, Pharmaceutics or related field

Job description

Regeneron Pharmaceuticals, Inc. seeks a Manager, Clinical Data Management (CDM), Study Lead to support clinical study teams and external partners on small or noncomplex studies or larger studies within a therapeutic area.

Coordinate all DM activities from study start-up to archiving, provide expertise in data management, support eCRF and database design, and ensure data quality. The role performs data quality reviews, data acceptance, and coordinates data transfers with CROs; maintains eTMF