Job Title: Clinical Data Manager II

Work Location: Orange County, California

Summary:

The Clinical Data Manager II will oversee and execute data management activities throughout the clinical study lifecycle. This role requires strong analytical skills, project management experience, and expertise with electronic data capture systems. The position involves cross-functional collaboration, data strategy input, and ensuring high-quality, audit-ready deliverables for clinical studies.

Responsibilities:

• Develop and manage essential study documentation, including Data Management Plans, Project Plans, and data review guidelines.
• Lead User Acceptance Testing for clinical databases and electronic data capture systems.
• Coordinate and facilitate cross-functional meetings with study teams and project stakeholders.
• Oversee the delivery of electronic data capture study milestones in alignment with project timelines.
• Drive data cleaning efforts, conduct regular data reviews, identify data quality issues, and generate queries as needed.
• Review study datasets for data integrity and compliance with industry standards.
• Support data reconciliation activities and collaborate with programming teams to generate customized reports.
• Maintain organized, audit-ready project documentation and contribute to process improvements within the department.

Qualifications:

• 2 to 5 years of relevant industry experience in Clinical Data Management.
• Experience in Pharmaceutical, Medical Device, Biotechnology, or CRO industries.
• Experience authoring Data Management documentation such as DMPs and edit check specifications.
• Project management experience and hands-on familiarity with CDISC Standards (CDASH, SDTM).
• Knowledge of FDA/ICH guidelines and industry standard practices for clinical data management.
• Proficiency with EDC systems (e.g., Inform, RAVE, iMedNet) and data review tools.
• Strong communication, organizational, and analytical skills with a focus on data quality.
• BS or higher in Biological Science, Nursing, or a related health science discipline preferred.
• Experience in Ophthalmology therapeutic area and with SQL, SAS, Excel, or other data analysis tools is a plus.

Published Category: Data Management & Programming