eTMF System Manager

eTMF System Ownership & Administration

AI Innovation & Digital Transformation

System Testing, Validation & Release Management

TMF Process Excellence

Compliance, Quality & Risk Management

Training & Stakeholder Engagement

Responsibilities

• Key Responsibilities
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Get to know Syneos Health
• Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
• No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
• http://www.syneoshealth.com
• Additional Information
• Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.