eTMF System Manager

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

Whether you join us in a Functional Service Provider partnership or a Full-Service setting, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.

We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.

We are committed to building an inclusive culture – where you can authentically be yourself. We are continuously building the company we all want to work for and our customers want to work with. Lead governance, configuration oversight, and lifecycle management of the eTMF platform.

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

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.

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.

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.

Training & Stakeholder Engagement

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.

Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. 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.

The eTMF Systems Manager, AI & Innovation is responsible for the strategic leadership, administration, optimization, and continuous improvement of electronic Trial Master File (eTMF) systems, with a primary focus on Veeva Vault eTMF. This role serves as the subject matter expert (SME) for TMF technology, ensuring system compliance, inspection readiness, operational efficiency, and alignment with evolving industry standards. The position leads system enhancements, testing and validation activities, AI-driven innovation initiatives, and process transformation efforts designed to improve TMF quality, completeness, timeliness, and user experience. The role partners closely with Clinical Operations, Quality, Technology Solutions, Data Analytics, and external technology vendors to ensure eTMF capabilities continue to support business growth and regulatory requirements.

📌 System Manager (Job Planning) (Secunderabad)
🏢 Syneos Health
📍 Secunderabad