Senior Clinical Data Manager: Lead Data & Compliance

Ocugen; Malvern (Chester County); Vor Ort; USD 110.000 - 150.000; Vollzeit

Zusammenfassung

Ocugen is seeking a Senior Clinical Data Manager to lead data management efforts across clinical development programs and marketed products. You will oversee data collection, database design, CRF development, data validation, and QA, while driving cross-study consistency and mentoring junior staff.

Responsibilities include vendor management, ensuring GCP/ICH/CDISC compliance, audit readiness, and collaboration with Clinical Operations, Biostatistics, and Regulatory teams.

Qualifikationen

• BS in sciences, nursing, or related field.
• 5–7 years clinical data management experience in biopharma or CRO.
• Strong knowledge of GCP, ICH, FDA, CDISC.
• Experience with EDC systems (Veeva preferred), CRFs, IRT.
• Excellent organizational, communication, and problem-solving skills.
• Detail-oriented and able to work in a fast-paced environment.

Aufgaben

• Oversee study data collection, database design, CRF development, data validation, and QA.
• Lead cross-study consistency across programs.
• Mentor junior staff and manage vendors.
• Ensure compliance with GCP, ICH, FDA, and CDISC standards.
• Support audit readiness and documentation.
• Collaborate with Clinical Operations, Biostatistics, and Regulatory teams.
• Develop data strategies and standards; author SOPs and DMPs.
• Participate in cross-functional project planning.

Kenntnisse

GCP

ICH

CDISC

FDA

EDC (Veeva)

CRFs

IRT

Organizational skills

Communication

Problem-solving

Detail-oriented

Ausbildung

BS in sciences/nursing or related

Tools

Veeva

Jobbeschreibung

Ocugen is seeking a Senior Clinical Data Manager to lead data management efforts across clinical development programs and marketed products. You will oversee data collection, database design, CRF development, data validation, and QA, while driving cross-study consistency and mentoring junior staff.

Responsibilities include vendor management, ensuring GCP/ICH/CDISC compliance, audit readiness, and collaboration with Clinical Operations, Biostatistics, and Regulatory teams.