Senior Clinical Data Manager — Data Leadership & QA

BioSpace; Malvern (Chester County); On-site; USD 120,000 - 160,000; Full time

Job summary

Ocugen is seeking a Senior Clinical Data Manager to lead data management efforts, oversee quality data collection, and drive critical data handling activities for clinical development programs and marketed products.

The candidate will provide leadership to junior staff, work with cross-functional teams, and ensure high-quality, timely deliverables while maintaining regulatory compliance and data standards.

Qualifications

• BS degree in clinical/biological/mathematical sciences, or nursing or equivalent.
• 5–7 years of clinical data management experience in biopharma or CRO.
• Experience with CRFs and development of EDC databases, IRT systems and diary apps.
• Veeva experience is preferred.
• Strong knowledge of GCP, ICH, FDA and CDISC regulatory requirements.
• Excellent attention to detail and timely deliverables.

Responsibilities

• Oversee studies or a program, mentor team members, and manage vendors.
• Make high-level decisions on data standards and risk-based management strategies.
• Lead inspection readiness and ensure document completeness across studies.
• Serve as SME during audits and guide SOP alignment with compliance expectations.
• Provide strategic input to Clinical Operations, Biostatistics, Programming and Quality on data flow and improvements.
• Lead the development and execution of data management plans (DMPs) and eCRF design.
• Collaborate with Biometrics, Clinical and Regulatory to implement protocols and data outputs.
• Develop and validate edit checks and validation reports to ensure data quality.
• Prepare for audits and ensure data management processes meet standards.

Skills

Clinical data management experience

CRFs and EDC development

GCP/ICH/FDA/CDISC knowledge

Attention to detail

Communication and collaboration

Veeva experience

Education

BS degree in clinical/biological/mathematical sciences or nursing

Job description

Ocugen is seeking a Senior Clinical Data Manager to lead data management efforts, oversee quality data collection, and drive critical data handling activities for clinical development programs and marketed products.

The candidate will provide leadership to junior staff, work with cross-functional teams, and ensure high-quality, timely deliverables while maintaining regulatory compliance and data standards.