Senior Clinical Data Manager — Lead Data Management

Katalyst CRO; Santa Clara (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Katalyst CRO seeks an experienced Data Management Lead to oversee data management activities across clinical studies and programs in Santa Clara, CA. The role blends hands-on DM tasks with governance, cross-functional collaboration, and process improvement.

You will review study protocols, design eCRFs, perform UAT, manage edit checks, QC data transfers, and ensure timely database locks while upholding CDISC/SDTM standards and SOPs.

Qualifications

• BS/BA in computer science or related discipline with 8+ years in pharma/CRO settings.
• Master's degree with 6+ years of similar experience.
• Strong knowledge of CDISC/CDASH/SDTM and FDA/industry guidelines.
• Ability to lead multiple teams and manage projects.
• Excellent communication, problem solving, and analytical thinking.

Responsibilities

• Leads, performs, and oversees data management activities for clinical studies and/or clinical programs
• Performs hands-on clinical data management tasks to support clinical studies, including reviewing study protocols, designing eCRFs, UAT, edit checks, QA of data transfers, and database lock activities
• Participate in, review, and lead development of policies, SOPs, processes, and documents for data management
• Promote data management at inter- and intradepartmental meetings
• Provide technical expertise to staff within Data Management and Biostatistics; develop and execute training
• Assist with responding to QA audits and ensure CAF closures
• Research industry trends and share information within NBI
• Recommend improvements to data management practices and procedures
• Assist in the development of standardized documents within data management
• Oversee screening, selection, validation, and implementation of data management software purchases and upgrades
• Participate in selecting outsourcing vendors and review data management sections of proposals, including scope of work; monitor budgets as appropriate
• Coordinate data management timelines for individual projects and clinical programs, including database lock, DSMB meetings, data review meetings, and monitoring CRO performance of data management tasks to ensure timelines are met
• Monitor in-house resources and identify deficiencies; work with supervisor to overcome obstacles
• Ensure quality control checks and audit procedures are implemented according to SOPs
• Run data review listings, issue queries, code Medical History and AE data using MedDRA dictionary and code Concomitant Medications using WHO Drug dictionary
• Collaborate with database programmer to ensure CDISC/SDTM standards are followed
• Identify areas of risk and proactively communicate issues and solutions
• Participate in data management-related NDA submission activities
• Provide feedback for performance evaluations and develop team members
• Perform other duties as assigned

Skills

Data management

Leadership

Project management

Quality assurance

Communication

Analytical thinking

Vendor management

Training

Education

BS/BA in Computer Science or related field

MS in Computer Science or related field

Tools

Medidata Rave

CDISC/CDASH/SDTM

Microsoft Word

Microsoft Excel

PowerPoint

SAS

Business Objects

Job description

Katalyst CRO seeks an experienced Data Management Lead to oversee data management activities across clinical studies and programs in Santa Clara, CA. The role blends hands-on DM tasks with governance, cross-functional collaboration, and process improvement.

You will review study protocols, design eCRFs, perform UAT, manage edit checks, QC data transfers, and ensure timely database locks while upholding CDISC/SDTM standards and SOPs.