Remote Clinical Data Management Study Lead

Regeneron Pharmaceuticals, Inc.; United States; À distance; USD 134 000 - 219 000; Plein temps

Avantages offerts par ce poste

Annual bonuses

Equity awards

401(k) matching

Health and wellness programs

Fitness centers

Insurance benefits

Paid time off

Family support benefits

Résumé du poste

Regeneron Pharmaceuticals, Inc. is seeking a Senior Manager, Clinical Data Management to lead our Data Management team across multiple trials in a hybrid/remote setup in the United States.

You will oversee study delivery, mentor data managers, and collaborate with CROs and external vendors to ensure high-quality data handling. You will manage start-up through database lock, ensure regulatory compliance (21 CFR Part 11, ICH-GCP, CDISC), and drive process improvements.

Qualifications

• 8+ years of clinical data management experience in biotech/pharma/health-related industries.
• Proven record of leading studies and study teams in a data processing environment.
• Knowledge of 21 CFR Part 11, ICH-GCP, and CDISC.
• Strong problem-solving, project management, and communication skills; ability to motivate virtual teams.
• 3+ years of people management experience preferred.
• Certified CCDM certification preferred.

Responsabilités

• Serve as the data management study lead and primary contact for study teams, CROs, and external data vendors across multiple trials.
• Oversee data management activities from study start-up through database lock and archiving.
• Provide sponsor oversight of CRO data management work, identifying gaps and driving them to resolution.
• Review and approve key study documentation, including data management plans, CRF design, and data transfer specifications.
• Maintain inspection readiness and eTMF documentation to meet quarterly compliance reviews.
• Monitor data quality, deliverable timelines, and risks, calling out issues proactively.
• Manage, coach, and develop data management staff, including recruitment and performance management.
• Recommend process improvements, lead cross-functional initiatives, and act as a subject matter expert delivering training.

Connaissances

Data management

Project management

Communication

Team leadership

Regulatory knowledge

Problem solving

Cross-functional collaboration

Leadership

Formation

Bachelor's degree in Math/Science

Description du poste

Regeneron Pharmaceuticals, Inc. is seeking a Senior Manager, Clinical Data Management to lead our Data Management team across multiple trials in a hybrid/remote setup in the United States.

You will oversee study delivery, mentor data managers, and collaborate with CROs and external vendors to ensure high-quality data handling. You will manage start-up through database lock, ensure regulatory compliance (21 CFR Part 11, ICH-GCP, CDISC), and drive process improvements.