Manager, Clinical Data Management (CDM), Study Lead

Regeneron Pharmaceuticals•Tarrytown, GA

9d•$172,994 - $187,400•Hybrid

About The Position

Regeneron Pharmaceuticals, Inc. seeks a Manager Clinical Data Management (CDM), Study Lead (Tarrytown, NY) to serve as the primary DM supporting clinical study teams and external partners on small or noncomplex studies or supporting larger studies within a given 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. 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. Telecommuting permitted.

Requirements

Bachelor’s degree in Mathematics, Pharmaceutical Science, Pharmaceutics or related field
6 years of clinical data management experience in biotechnology, pharmaceutical, or health-related industry.
Experience with applying applicable regulations, including 21 CFR Part 11, ICH GCP Guidelines, and CDISC standards, to clinical data collection and management activities.
Experience supporting and coordinating clinical studies and study teams within a regulated data processing environment.
Experience applying data management processes and industry best practices across the clinical data lifecycle, including data collection, validation, and delivery.
Experience evaluating existing data management workflows and recommending process improvements to meet study and organizational objectives.
Experience resolving complex data related issues by analyzing requirements, identifying root causes, and implementing compliant solutions.
Experience preparing and delivering written documentation and verbal communications for crossfunctional clinical study teams.
Experience collaborating with crossfunctional, geographically distributed study teams in a matrixed environment.

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.