Senior Clinical Data Manager – EDC & CDISC Lead

Katalyst CRO; Jacksonville (FL); On-site; USD 95,000 - 140,000; Full time

Job summary

Katalyst CRO is seeking an experienced Lead Clinical Data Manager in Jacksonville, FL to drive data management across complex studies from startup through database lock. You will design and manage EDC databases, maintain study documentation, and ensure data quality with robust validation and cleaning processes.

You will collaborate with clinical operations, biostatistics, and regulatory teams, oversee vendor relations, and advance data management systems and tools to improve trial efficiency.

Qualifications

• Bachelor's or master's in life sciences, health informatics, computer science, or related field.
• Strong understanding of data structure and data systems.
• Minimum of 5+ years of experience in clinical data management.
• Proficiency with EDC systems (Medidata Rave, Medrio).
• Strong understanding of CDISC standards (CDASH, SDTM, ADaM) and coding.
• Familiarity with data reporting tools is a plus.
• Thorough understanding of regulatory requirements (FDA, EMA) and GCP.
• Strong leadership and ability to manage multiple priorities.

Responsibilities

• Lead clinical data management activities for multiple complex studies from startup to final reporting.
• Develop and manage data management timelines for multiple projects.
• Design and oversee databases using EDC systems (Medidata, Medrio or similar).
• Maintain data management documentation across studies.
• Ensure accurate data capture with validation checks and edit checks.
• Oversee data validation, cleaning, discrepancy management and queries.
• Ensure compliance with regulatory requirements and industry standards.
• Prepare regulatory submissions and support data auditing processes.
• Collaborate with clinical operations, biostatistics, medical writing, and regulatory teams.
• Serve as primary contact for data management vendors and external partners.
• Manage CRO biostatistical services and budgetary efficiency.
• Develop and improve clinical data management processes and systems.
• Lead initiatives to enhance efficiency and evaluate new tools and methodologies.

Skills

EDC systems

CDISC standards

GCP compliance

Project management

Vendor management

FDA/EMA regulations

Leadership

Data quality

Education

Bachelor's degree in life sciences

Master's degree in health informatics or life sciences

Tools

Medidata Rave

Medrio

Job description

Katalyst CRO is seeking an experienced Lead Clinical Data Manager in Jacksonville, FL to drive data management across complex studies from startup through database lock. You will design and manage EDC databases, maintain study documentation, and ensure data quality with robust validation and cleaning processes.

You will collaborate with clinical operations, biostatistics, and regulatory teams, oversee vendor relations, and advance data management systems and tools to improve trial efficiency.