# eTMF System Manager

**Company**: Syneos Health
**Location**: IND-Hyderabad-Hybrid
**Work arrangement**: hybrid
**Job type**: full-time
**Category**: Operations
**Industry**: Healthcare

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/IND-Hyderabad-Hybrid/eTMF-System-Manager_25113089?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_0bc43e4b-adb

## Description

Syneos Health is seeking an eTMF System Manager to serve as the primary business owner and SME for Veeva Vault eTMF. The successful candidate will lead governance, configuration oversight, and lifecycle management of the eTMF platform, manage system enhancements, user requirements, prioritization, and release planning, and partner with technology teams and vendors to resolve complex system issues and implement improvements.

**Key Responsibilities**

**eTMF System Ownership & Administration**

- Serve as the primary business owner and SME for Veeva Vault eTMF.

- Lead governance, configuration oversight, and lifecycle management of the eTMF platform.

- Manage system enhancements, user requirements, prioritization, and release planning.

- Partner with technology teams and vendors to resolve complex system issues and implement improvements.

- Oversee TMF system integrations, data migrations, archival activities, and document transfers.

- Ensure system compliance with regulatory requirements, company procedures, and industry standards.

**AI Innovation & Digital Transformation**

- Lead the evaluation, implementation, and expansion of AI-enabled TMF capabilities.

- Drive innovation initiatives focused on automated document classification, metadata population, quality checks, and workflow optimization.

- Collaborate with AI vendors, technology teams, and operational stakeholders to define use cases, requirements, and success metrics.

- Monitor AI performance, identify improvement opportunities, and maintain feedback loops to improve model accuracy.

- Evaluate emerging technologies and industry trends to enhance TMF operational efficiency and inspection readiness.

**System Testing, Validation & Release Management**

- Lead User Acceptance Testing (UAT) and business validation activities for Veeva Vault releases and enhancements.

- Develop testing strategies, test scripts, execution plans, and defect management processes.

- Coordinate testing across functional stakeholders and ensure timely completion of validation activities.

- Assess business impact of system changes and ensure readiness for deployment.

- Support validation documentation and change control activities in accordance with applicable quality requirements.

**TMF Process Excellence**

- Act as a TMF SME supporting business process design, optimization, and standardization.

- Partner with operational teams to improve TMF quality, completeness, timeliness, and inspection readiness.

- Support implementation of TMF Reference Model updates, TMF standards, and metadata governance.

- Develop and maintain system-related procedures, job aids, training materials, and best practices.

- Provide expert consultation on TMF processes, technology capabilities, and risk mitigation strategies.

**Compliance, Quality & Risk Management**

- Monitor eTMF system compliance and data integrity.

- Conduct audit trail reviews, system risk assessments, and trend analyses.

- Support internal audits, regulatory inspections, and customer audits as required.

- Investigate system-related deviations and implement corrective and preventive actions.

- Ensure inspection-ready system documentation and operational controls are maintained.

**Training & Stakeholder Engagement**

- Develop and deliver training for system users and business stakeholders.

- Provide expert consultation and support for study teams, TMF Operations, and external customers.

- Lead communication and change management efforts associated with new system capabilities.

- Facilitate governance meetings and provide updates on system performance, enhancement priorities, risks, and innovation initiatives.

## Skills

### Required
- Veeva Vault eTMF
- AI-enabled TMF capabilities
- TMF process excellence
- compliance
- quality management

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Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/IND-Hyderabad-Hybrid/eTMF-System-Manager_25113089?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)