Clinical Data Systems Lead — Study Build & CTMS

Theoris; Indianapolis (IN); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health Insurance

401(k) plan

PTO

Paid holidays

Job summary

Theoris is seeking a Senior Clinical Data Systems Analyst in Indianapolis, IN to own critical study build and post-production change processes across EDC, CTMS (Veeva Vault), and related platforms. You will manage change requests, study build review cycles, validation governance, and CTMS integrations in a highly regulated pharmaceutical environment.

The role requires strong troubleshooting, project coordination, cross-functional collaboration, and attention to procedural alignment in a

Qualifications

• Experience with Change Management processes and documentation practices.
• Clinical data management systems and processes including EDC, CTMS/Veeva Vault and related platforms.
• Strong troubleshooting, issue triage/escalation, and root-cause analysis skills.
• Project/release management experience including planning and coordination.
• Document control and inventory tracking for procedural alignment.
• CSV fundamentals and governance design experience.
• Inventory and configuration management (versioning, ownership, code location tracking).
• Excellent communication and customer-service orientation for cross-team collaboration.
• Ability to partner with both technical and non-technical stakeholders without direct authority.

Responsibilities

• Provide Post-Production Change Request System Support, including maintenance, troubleshooting, and issue tracking across multiple teams.
• Deliver Process Support by maintaining accurate process documents and attending study build meetings as needed.
• Own Study Build Review Cycles Management, including timelines, releases, training, and documentation maintenance.
• Support Study Build Automation Programs Validation Governance and maintain program history and adoption through training materials and follow-ups.
• Provide CTMS Master Protocol (MP) Integration Support, troubleshooting EDC-to-CTMS data transfers and supporting MP design configuration.
• Provide CTMS Traditional Integration Support, troubleshooting integrations and disabling completed studies as needed.

Skills

Change Management

Clinical data management

EDC

CTMS/Veeva Vault

Root-cause analysis

Project management

Document control

CSV governance

Inventory management

Communication skills

Tools

ServiceNow

CDB

Veeva Vault

EDC

Job description

Theoris is seeking a Senior Clinical Data Systems Analyst in Indianapolis, IN to own critical study build and post-production change processes across EDC, CTMS (Veeva Vault), and related platforms. You will manage change requests, study build review cycles, validation governance, and CTMS integrations in a highly regulated pharmaceutical environment.

The role requires strong troubleshooting, project coordination, cross-functional collaboration, and attention to procedural alignment in a