Senior Clinical Data Systems Analyst

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

JOB TITLE: Senior Clinical Data Systems Analyst

LOCATION: Indianapolis, IN (Onsite 3 days/week)

INDUSTRY: Pharmaceutical

***NO C2C***

JOB DESCRIPTION:

We are seeking a detail-oriented, process-driven Clinical Systems / Study Build Process Specialist to support critical post-production change management, study build review cycles, documentation governance, automation validation, and CTMS integration activities for a leading pharmaceutical client. You will own key systems and processes that ensure accurate, compliant, and efficient clinical study design and data flows across EDC, CTMS (Veeva Vault), and related platforms. This role requires strong troubleshooting, project coordination, cross-functional partnership, and a customer-service mindset in a highly regulated environment.

RESPONSIBILITIES:

• Provide Post-Production Change Request System Support (≈25%): Understand Change Management processes and documentation practices; lead and plan annual (minimum) request system updates; partner with Study Build, eCOA, CDA/CDM, and Data Analytics teams to gather feedback and drive improvements; deliver ongoing maintenance, troubleshooting, issue triage/escalation, performance monitoring, and maintain a log of known issues, fixes, and workarounds.
• Deliver Process Support (≈5%): Partner with CDRS Process SMEs to keep process documents accurate, current, and aligned with CDOS, procedures, strategy, and system functionality; attend study build meetings as needed; follow up on end-user questions and cross-system linkages (e.g., CDB, coder).
• Own Study Build Review Cycles Management (≈30%): Plan and manage review cycles including updates, timelines, releases, and training; maintain the Document Inventory Tracker; develop and communicate a recurring review cycle calendar; coordinate release planning and ensure training materials are current; serve as primary point of contact for questions and conflicts; maintain all technical process documentation related to daily Study Build activities so it stays aligned with current practices and procedures.
• Support Study Build Automation Programs Validation Governance (≈20%): Facilitate transition of validation governance ownership to the Study Build Team (effective January; process understanding starting mid-November); implement a formal request system (e.g., ServiceNow) for automation program updates; maintain inventory of programs (versions, owners, code locations, update history); provide training/reference materials and confirm adoption through follow-up checks.
• Provide CTMS Master Protocol (MP) Integration Support (≈10%): Troubleshoot EDC-to-Veeva Vault CTMS data transfer issues; support MP design configuration and act as liaison between Study Build and CTMS teams; track new Design MP trials and maintain status tracker; support transition from VETL to CHETL including EDC testing and issue resolution.
• Provide CTMS Traditional Integration Support (<5%): Troubleshoot EDC-to-CTMS integration issues and disable integration for studies that have completed database lock.

REQUIREMENTS:

• Working knowledge of (or ability to quickly learn) Change Management processes and documentation practices
• Experience with clinical data management systems and processes (EDC, CTMS/Veeva Vault, related platforms such as CDB, coder, eCOA)
• Strong system troubleshooting, issue triage/escalation, and root-cause analysis skills
• Project/release management experience including planning, timeline management, and coordination
• Document control, inventory tracking, and attention to detail for procedural alignment
• Computer System Validation (CSV) fundamentals and governance process design experience
• Inventory and configuration management (versioning, ownership, code location tracking)
• Excellent communication skills and customer-service orientation for cross-team collaboration
• Ability to partner effectively with technical and non-technical stakeholders without direct authority

DESIRED:

• Prior experience supporting study build, post-production change systems, or clinical systems governance in a pharmaceutical or biotech environment
• Hands‑on experience with ServiceNow or similar request/ticketing systems
• Familiarity with Master Protocol designs and multi-study EDC-to-CTMS data transfer configurations
• Experience developing training materials and driving process adoption/transition

BEST-IN-CLASS-BENEFITS:

We are in the people business; treating people right is our ONLY priority. Theoris Services consultants are full‑time employees with full benefits, including:

• Robust Health Insurance
• 401(k) plan
• PTO
• Paid holidays

ABOUT THEORIS:

Our goal is to Fuel Your Career! As a Theoris team member, you join a culture based on people-centered values and an environment that fosters both personal and professional growth. We build long-term relationships with our clients and our consultants. With over 30 years of building strong relationships in the industry, we’re uniquely positioned to make the right connections. This knowledge is used to find the right job placement. Our recruiting teams are experts dedicated to the information technology and engineering staffing space and are highly respected by our client base.