Senior Clinical Data Manager - Lead Data Strategy

OCUGEN OPCO INC; Malvern (Chester County); On-site; USD 110,000 - 170,000; Full time

Job summary

Ocugen is seeking a Senior Clinical Data Manager to lead data management efforts, oversee quality data collection and management, and guide CRF design, database design, and data monitoring for clinical development programs and marketed products.

You will provide mentorship to junior staff, ensure high-quality data deliverables, and collaborate with Clinical Operations, Biostatistics, and Regulatory teams to streamline data workflows and maintain compliance with GCP, ICH, and CDISC standards.

Qualifications

• BS degree in clinical, biological or mathematical sciences, or related field.
• 5-7 years of clinical data management experience in biopharma or CRO.
• Strong knowledge of GCPs, ICH, FDA and CDISC requirements.

Responsibilities

• Oversee studies or a program, ensure cross-study consistency and mentor team members.
• Lead data management strategies, protocol-driven design choices and risk-based approaches.
• Lead inspection readiness and ensure documentation completeness across studies.
• Collaborate with cross-functional teams to ensure data quality and timely deliverables.
• Develop and validate edit checks and data validation reports.

Skills

Clinical data management

GCP/ICH/CDISC

Leadership

EDC systems (Veeva)

Regulatory knowledge

Education

BS degree in clinical, biological or mathematical sciences

Tools

Veeva

EDC databases

Job description

Ocugen is seeking a Senior Clinical Data Manager to lead data management efforts, oversee quality data collection and management, and guide CRF design, database design, and data monitoring for clinical development programs and marketed products.

You will provide mentorship to junior staff, ensure high-quality data deliverables, and collaborate with Clinical Operations, Biostatistics, and Regulatory teams to streamline data workflows and maintain compliance with GCP, ICH, and CDISC standards.