Senior Data Manager

Regeneron Pharmaceuticals; Montgomery (AL); On-site; USD 120,000 - 160,000; Full time

Job summary

Regeneron Pharmaceuticals seeks a Senior Clinical Data Manager to lead data management activities across multiple trials, from start‑up to archiving, ensuring timely, on‑budget delivery with stringent regulatory adherence.

You will serve as the study DM lead and POC for clinical study teams and CROs, providing expert guidance in eCRF design, data quality, transfers, and database lock, while mentoring virtual teams in a matrix environment.

Qualifications

• Working understanding of all applicable regulations, including 21 CFR Part 11, ICH‑GCP Guidelines, and CDISC standards for data collection.
• Proven record of leading clinical studies in a data processing environment and robust knowledge of Data Management processes and industry standard methodologies.
• Strong problem‑solving, project management, and presentation skills.
• Ability to work efficiently with and empower virtual teams in a matrix environment and understanding of cross‑functional activities.
• Proficient with appropriate EDC applications and Microsoft Office applications; software proficiency with CDMS required; experience with JMP and SAS a plus.
• Bachelor’s degree in Mathematics, Science or a related field with a minimum of 5+ years of clinical data management experience in biotech, pharmaceutical or health‑related industry.

Responsibilities

• Provide a high level of expertise in data management to support clinical studies.
• Provide clear verbal or written information and hands‑on support to project team members and to CROs related to eCRF and database design, data quality, and reporting of database/data quality status.
• Own the implementation and execution of procedures for data quality review and data acceptance prior to data analyses and/or database lock.
• Lead data transfers with CROs and third‑party data sources, SAE/AE reconciliation and MedDRA/WHO‑DD coding.
• Support the transfer, locking, and archiving of study databases.
• Lead scheduling and time constraints across multiple projects.
• Prepare recommendations for new or improved processes for data management and data flow.

Skills

Data management leadership

Regulatory compliance

Project management

Communication/presentation

Cross-functional collaboration

Education

Bachelor’s degree in Mathematics/Science or related field

Tools

CDMS

SAS

JMP

EDC applications

Microsoft Office

Job description

Overview

The Senior Clinical Data Manager will serve as the DM study lead and point of contact for clinical study teams and external partners for multiple trials within a given Therapeutic Area (TA). Lead all aspects of DM activities across all stages of the trial from study start‑up through archiving to achieve data management results within the assigned drug assets and goals to ensure timely completion within project budget guidelines and adhering to all applicable policies and procedures.

Typical Day

• Provide a high level of expertise in data management to support clinical studies.
• Provide clear verbal or written information and hands‑on support to project team members and to CROs related to eCRF and database design, data quality, and reporting of database/data quality status.
• Own the implementation and execution of procedures for data quality review and data acceptance prior to data analyses and/or database lock.
• Lead data transfers with CROs and third‑party data sources, SAE/AE reconciliation and MedDRA/WHO‑DD coding.
• Support the transfer, locking, and archiving of study databases.
• Lead scheduling and time constraints across multiple projects.
• Prepare recommendations for new or improved processes for data management and data flow.

Qualifications

• Working understanding of all applicable regulations, including 21 CFR Part 11, ICH‑GCP Guidelines, and CDISC standards for data collection.
• Proven record of leading clinical studies in a data processing environment and robust knowledge of Data Management processes and industry standard methodologies.
• Strong problem‑solving, project management, and presentation skills.
• Ability to work efficiently with and empower virtual teams in a matrix environment and understanding of cross‑functional activities.
• Proficient with appropriate EDC applications and Microsoft Office applications; software proficiency with CDMS required; experience with JMP and SAS a plus.
• Bachelor’s degree in Mathematics, Science or a related field with a minimum of 5+ years of clinical data management experience in biotech, pharmaceutical or health‑related industry.

Benefits

We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.

EEO Statement

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company’s business.