Project Manager II – Veeva Vault Clinical (CTMS & eTMF)
Company: Syneos Health
Location: USA (Remote – Alaska listed)
Job ID: 25108377
Level: Project Manager II (Sponsor-dedicated / Clinical Systems SME role)
Focus: Veeva Vault Clinical (CTMS & eTMF)
Role Overview
This role is a hybrid operational + strategic system ownership position responsible for managing and optimizing Veeva Vault Clinical systems (CTMS and eTMF) in a post–go-live sponsor environment.
The role combines:
~50% hands-on operational support
~50% strategic governance and program management
It acts as a system SME and escalation point for clinical operations and system governance.
Key Responsibilities
1. System Ownership & Operational Support
Act as primary business owner of Veeva Vault Clinical in production
Provide centralized support for CTMS and eTMF users
Serve as escalation point for system and process issues
Coordinate issue resolution across clinical, IT, and quality teams
2. Governance & Compliance
Ensure inspection readiness of CTMS and eTMF systems
Maintain strong change control and configuration management
Support data governance processes
Manage and triage change requests from business users
Ensure compliance with GxP regulations
3. Change & Release Management
Partner with Clinical Systems and IT teams for system changes
Conduct impact assessments for system updates
Support release activities:
Training updates
Communication plans
SOP revisions
Ensure alignment between system functionality and clinical workflows
4. Stakeholder Management
Act as SME and advisor to:
Clinical Operations
Quality teams
IT / Systems teams
Communicate system updates and operational changes
Work with vendors and FSP partners to ensure accountability
5. Training & Enablement
Develop training materials, job aids, and user guides
Deliver training sessions for system users
Support onboarding and continuous system education
6. Program & Project Support
Support Business Process Owners (BPOs) and Program Leads
Participate in workshops and system optimization initiatives
Contribute to continuous improvement of Veeva Vault processes
Ensure smooth integration of Vault into clinical programs
Required Qualifications
Experience
5+ years working with GxP-regulated clinical systems
Strong expertise in:
CTMS (Clinical Trial Management System)
eTMF (electronic Trial Master File)
3+ years project management experience in clinical research
Technical Skills
Strong Veeva Vault Clinical expertise:
System configuration (backend)
End-user workflows (frontend)
Experience with system implementation or post-go-live support
Knowledge of clinical trial operations and vendor management
Regulatory Knowledge
GxP compliance
Good Clinical Practice (GCP)
Data integrity and inspection readiness requirements
Key Competencies
Strong stakeholder influence in matrix environments
Problem-solving and escalation management
Ability to translate system issues into business solutions
Decision-making with risk awareness
Strong understanding of system governance vs operational execution
Job Nature Summary
This is a high-ownership Veeva Vault SME role, not an entry-level PM job.
You will:
Own CTMS & eTMF operations after go-live
Manage system governance and compliance
Act as the bridge between clinical operations, IT, and quality
Ensure systems remain inspection-ready and fully functional
Drive improvements in clinical system processes
Salary (USA)
$95,000 – $175,700 USD (depending on experience and skills)
Position Type
Sponsor-dedicated clinical systems role
Remote (USA-based)
High visibility, cross-functional leadership role
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