Senior Clinical Data Manager: Data Strategy & Mentorship

BioSpace; Malvern (Chester County); On-site; USD 110,000 - 145,000; Full time

Job summary

Ocugen seeks a Senior Clinical Data Manager to lead data management across programs and oversee quality data collection and processes for clinical trials and marketed products.

You will design CRFs, oversee database design, monitoring, validation, and ensure compliance with GCP, ICH, FDA, and CDISC standards while mentoring junior staff and coordinating with Biometrics, Clinical, and Regulatory teams.

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 environment.
• Experience with CRFs, development of EDC databases, IRT systems and diary applications for data collection. Veeva experience is preferred.
• Strong knowledge of GCPs, ICH, FDA, and CDISC regulatory requirements governing clinical studies.
• Demonstrated attention to detail and outstanding organization skills.
• Self-motivated with a commitment to high quality, on-time deliverables.
• Excellent communication and collaboration skills with a team-oriented approach.

Responsibilities

• Oversee studies or a program, ensuring cross-study consistency and mentoring team members.
• Make higher level decisions on data standards, risk-based data management strategies, and protocol-driven design choices.
• Lead inspection readiness and ensure documentation completeness across studies.
• Serve as SME during audits and guide SOP alignment with GCP, ICH, CDISC requirements.
• Provide strategic input to Clinical Operations, Biostatistics, Programming, and Quality on data flow and database improvements.
• Lead the development and execution of data management plans (DMPs) and eCRF designs.
• Develop and validate edit checks and validation reports to maintain high-quality data.
• Prepare for and participate in audits and ensure compliance with data management processes.

Skills

Attention to detail

Communication

Team collaboration

Time management

Education

Bachelor's degree in clinical/biological/scientific field or nursing qualification

Tools

Veeva

Job description

Ocugen seeks a Senior Clinical Data Manager to lead data management across programs and oversee quality data collection and processes for clinical trials and marketed products.

You will design CRFs, oversee database design, monitoring, validation, and ensure compliance with GCP, ICH, FDA, and CDISC standards while mentoring junior staff and coordinating with Biometrics, Clinical, and Regulatory teams.