Veeva Clinical (CTMS, ODC, Site Connect, EDC/CDB)

Experience: 10-15 years hands-on

Job Summary:
Responsible for implementing, configuring, and supporting Veeva Clinical applications including CTMS, EDC, CDB, Site Connect, and ODC. Collaborate with clinical operations, data management, sponsors, CROs, and study teams to ensure efficient clinical trial execution, data quality, and regulatory compliance throughout the study lifecycle. Veeva's clinical platform is designed to connect clinical operations and clinical data management on a unified cloud platform.

Roles and Responsibilities

• Configure and support Veeva CTMS for study planning, site management, monitoring visits, milestones, and issue tracking.
• Build and maintain Veeva EDC studies, including eCRFs, edit checks, visit schedules, and subject management.
• Perform clinical data review, query generation, reconciliation, and database cleaning using Veeva CDB (Clinical Database/Data Workbench).
• Support Veeva Site Connect to streamline communication and data exchange between sponsors, CROs, and clinical sites.
• Configure ODC/Open Data Capture (or OpenEDC where applicable) for integration with external data sources and third-party EDC systems.
• Coordinate User Acceptance Testing (UAT), system validation, and production deployments.
• Monitor data quality and resolve discrepancies to support timely database lock.
• Create and maintain study documentation, validation documents, SOPs, and user guides.
• Collaborate with Clinical Operations, Data Management, Biostatistics, Medical Coding, and Safety teams.
• Support protocol amendments, mid-study changes, and system enhancements.
• Manage user access, roles, permissions, and security within the Veeva Vault platform.
• Troubleshoot application issues and provide end-user training and production support.
• Ensure compliance with ICH-Google Cloud Platform, FDA 21 CFR Part 11, and applicable regulatory requirements.

Required Skills

• Experience with Veeva CTMS
• Experience with Veeva EDC
• Knowledge of Veeva CDB/Data Workbench
• Experience with Veeva Site Connect
• Knowledge of ODC/OpenEDC integrations
• Clinical trial lifecycle knowledge (Phase I–IV)
• Clinical Data Management (CDM)
• eCRF design and edit check configuration
• Query management and data cleaning
• UAT and system validation
• SQL (preferred)
• SDTM/CDISC basics
• Strong analytical and communication skills

Preferred Qualifications

• Bachelor's or Master's degree in Life Sciences, Pharmacy, Biotechnology, or a related field.
• Experience working with pharmaceutical companies or CROs.
• Knowledge of Agile or Waterfall project methodologies.
• Experience with Veeva Vault administration is an advantage.