Lead Clinical Data Manager - Data Strategy & Compliance

Ocugen; Malvern (Chester County); On-site; USD 90,000 - 130,000; Full time

Job summary

Ocugen seeks a Senior Clinical Data Manager to lead data management efforts across clinical development programs and marketed products. You will guide database design, CRF development, data monitoring, and validation while mentoring junior staff and coordinating with cross-functional teams to ensure timely, high-quality deliverables.

Responsibilities include data standards decisions, inspection readiness, and collaboration with Biometrics, Clinical, and Regulatory teams to ensure accurate

Qualifications

• BS degree in clinical, biological or mathematical sciences, or nursing qualification, or work-related equivalent.
• 5-7 years of clinical data management experience in biopharma or CRO environments.
• Strong knowledge of GCP, ICH, FDA and CDISC regulatory requirements.
• Experience with CRFs, and development of EDC databases, IRT systems and diary applications.
• Veeva experience is preferred.

Responsibilities

• Oversee studies or a program, ensuring cross-study consistency and mentoring team members.
• Make high-level decisions on data standards and risk-based data management strategies.
• Lead inspection readiness and ensure documentation completeness across studies.
• Provide SME input during audits and ensure SOP alignment and compliance with GCP/ICH/CDISC.
• Collaborate with Clinical Operations, Biostatistics, Programming and Quality on data flow and standards.

Job description

Ocugen seeks a Senior Clinical Data Manager to lead data management efforts across clinical development programs and marketed products. You will guide database design, CRF development, data monitoring, and validation while mentoring junior staff and coordinating with cross-functional teams to ensure timely, high-quality deliverables.

Responsibilities include data standards decisions, inspection readiness, and collaboration with Biometrics, Clinical, and Regulatory teams to ensure accurate