Associate Director, External Data Strategy & Delivery

BioSpace; New Jersey; Ibrido; USD 155.000 - 253.000; Tempo pieno

Descrizione del lavoro

Regeneron is seeking an Associate Director to join the Clinical Data Management team in Warren, NJ. This hybrid role (4 days on site) involves leading external data acquisition, quality oversight, and data delivery strategies across the clinical trial portfolio.

You will mentor a team of EDAD Managers and collaborate with cross-functional groups to ensure data integrity and timely study delivery. A strong background in external data types and regulatory standards is required.

Competenze

• 10+ years in Clinical Data Acquisition/Management in biotech/pharma/healthcare.
• 4+ years of people management experience.
• Experience overseeing external data reconciliation between EDC systems and vendor platforms.
• Experience driving process improvements and vendor oversight in supervised environments.
• Strong leadership, coaching, and mentoring capabilities.
• Excellent problem solving, analytical and communication skills.

Mansioni

• Lead External Data Acquisition, integration, quality oversight, and delivery strategy across trials.
• Serve as portfolio-level lead for external data quality and clinical-data operations strategy.
• Review protocol requirements, vendor specs, and data flows; develop DTS documents to Regeneron standards.
• Mentor EDAD Managers, Specialists, and associates; support SOPs, audits, and inspections.
• Oversee vendor onboarding, qualification, governance, KPIs, SLAs, and performance monitoring.
• Collaborate with DB Development, Biostatistics, Study Data Managers, and vendors to resolve data discrepancies.
• Drive process improvements and implement innovative external data solutions.

Descrizione del lavoro

Regeneron is seeking an Associate Director to join the Clinical Data Management team in Warren, NJ. This hybrid role (4 days on site) involves leading external data acquisition, quality oversight, and data delivery strategies across the clinical trial portfolio.

You will mentor a team of EDAD Managers and collaborate with cross-functional groups to ensure data integrity and timely study delivery. A strong background in external data types and regulatory standards is required.