Senior Clinical Data Manager - Data Leadership & Compliance

BioSpace; Malvern (Chester County); On-site; USD 120,000 - 150,000; Full time

Job summary

Ocugen is seeking a Senior Clinical Data Manager to lead data management across clinical development programs. You will oversee data collection, database design, CRF development, and data validation, while mentoring junior team members.

You will collaborate with Clinical Operations, Biostatistics and Regulatory teams to ensure timely, accurate data delivery and audit readiness, applying GCP/ICH/CDISC standards throughout the data lifecycle.

Qualifications

• 5–7 years of clinical data management experience in biopharma or CRO environments.
• Must have experience with clinical trials and data collection processes.
• Experience with CRFs and development of EDC databases, IRT, and diary applications (Veeva preferred).
• Strong knowledge of GCP, ICH, FDA and CDISC regulatory requirements.
• Excellent attention to detail and organization, with ability to deliver on time.
• Self-motivated with strong communication and collaboration skills.

Responsibilities

• Lead data management efforts across studies or programs and mentor staff.
• Make high-level decisions on data standards and risk-based data management strategies.
• Oversee audits, inspection readiness and documentation completeness.
• Partner with Biometrics, Clinical and Regulatory teams to ensure proper data outputs.
• Develop and validate edit checks and DMPs to ensure data quality and flow.
• Drive continuous data management process improvements and risk mitigation.

Skills

Attention to detail

Organizational skills

Communication skills

Timelines management

Problem solving

Team collaboration

Regulatory knowledge

Clinical trials experience

EDC databases

IRT systems

Diary applications

Veeva

Education

BS degree in clinical, biological or mathematical sciences, or nursing qualification, or work-related equivalent

Tools

Veeva

Job description

Ocugen is seeking a Senior Clinical Data Manager to lead data management across clinical development programs. You will oversee data collection, database design, CRF development, and data validation, while mentoring junior team members.

You will collaborate with Clinical Operations, Biostatistics and Regulatory teams to ensure timely, accurate data delivery and audit readiness, applying GCP/ICH/CDISC standards throughout the data lifecycle.