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Project Manager Ii – Veeva Vault Clinical (Ctms & Etmf)

Syneos Health
Syneos Health
5+ years
Not Disclosed
Remote, USA, Remote
10 May 6, 2026
Job Description
Job Type: Full Time Hybrid Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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