Senior Clinical Data Manager - Trials & Data Quality

Katalyst CRO; Princeton (NJ); On-site; USD 120,000 - 160,000; Full time

Job summary

Katalyst CRO in Princeton, NJ is seeking a hands-on Clinical Data Manager to lead data management activities across multiple complex studies from startup through database lock and final reporting. The role requires strong leadership, project management, and deep knowledge of data standards.

You will design and oversee EDC implementations (Medidata Rave, Medrio), ensure data quality, coordinate with clinical operations, biostatistics, regulatory teams, and mentor junior staff while improving

Qualifications

• Bachelor's or Master's degree in life sciences, health informatics, computer science, or related field.
• Strong data structure and data systems understanding.
• Minimum 5+ years in clinical data management across studies.
• Proficiency with EDC systems such as Medidata Rave or Medrio.
• Knowledge of CDISC standards (CDASH, SDTM, ADaM) and coding (WHO Drug, MedDRA).
• GCP and regulatory knowledge (FDA/EMA) and data reporting familiarity.
• Leadership, project management, and ability to juggle multiple priorities.
• Excellent communication and cross-functional collaboration.
• CCDM or similar certification preferred.

Responsibilities

• Lead clinical data management activities from startup to database lock and final reporting.
• Develop and manage data management timelines for multiple projects.
• Design, build, and oversee EDC databases using Medidata, Medrio, or similar.
• Maintain all data management documentation for clinical studies.
• Ensure accurate data capture with validation checks and edit checks.
• Oversee data validation, cleaning, discrepancy management, and query resolution.
• Ensure data accuracy, completeness, and regulatory compliance (FDA/EMA, CDISC).
• 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.

Skills

Leadership

Project management

Communication skills

Clinical data management

EDC systems proficiency

Education

Bachelor's or Master's in life sciences/related

CCDM certification

Tools

Medidata Rave

Medrio

Job description

Katalyst CRO in Princeton, NJ is seeking a hands-on Clinical Data Manager to lead data management activities across multiple complex studies from startup through database lock and final reporting. The role requires strong leadership, project management, and deep knowledge of data standards.

You will design and oversee EDC implementations (Medidata Rave, Medrio), ensure data quality, coordinate with clinical operations, biostatistics, regulatory teams, and mentor junior staff while improving