Senior Clinical Data Manager

Ocugen; Malvern (Chester County); Presencial; USD 110 000 - 150 000; Tempo integral

Resumo da oferta

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.

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

GCP

ICH

CDISC

FDA

EDC (Veeva)

CRFs

IRT

Organizational skills

Communication

Problem-solving

Detail-oriented

Formação académica

BS in sciences/nursing or related

Ferramentas

Veeva

Descrição da oferta de emprego

Role: Senior Clinical Data Manager leading data management efforts within Ocugen's clinical development programs and marketed products.

Responsibilities

• oversee study data collection, database design, CRF development, data validation, and quality assurance
• lead cross-study consistency
• mentor junior staff
• manage vendors
• ensure compliance with GCP, ICH, 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

Requirements

• BS in sciences, nursing, or related
• 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
• capable of working in fast-paced environment

High Value

• clinical trials
• data management
• GxP compliance
• EDC/database design
• audit readiness
• cross-functional collaboration

Work Setup

• primarily office-based with limited remote work
• may require outside hours for business needs