This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ business community. Please do not contact the recruiter directly. Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Job Responsibilities: Basic purpose of the role: The Clinical Document Specialist plays a critical role in ensuring the completeness, quality, and inspection readiness of the TMF across the clinical portfolio. Operating within the Documentation Management function of CDO Study Management, the Specialist leads TMF oversight activities that directly impact regulatory compliance, audit outcomes, and trial delivery success. This role is accountable for managing and optimizing TMF operations, including expected document planning, document filing, quality control, archiving and inspection preparation while applying risk-based oversight through metrics, audits, and data-driven insights The Specialist collaborates cross-functionally with study teams,



vendors and global stakeholders to ensure timely and accurate documentation practices and contributes to the continuous improvement of TMF processes, tools, and standards. With deep expertise in GCP, regulatory requirements, and eTMF systems, the clinical document specialist influences documentation strategy, supports inspection readiness across programs, and drives operational excellence in clinical documentation management. The successful candidate will be skilled with: Robust expertise in Veeva Clinical Suite and associated processes, with the ability to quickly understand system capabilities and constraints. Capable of independently taking ownership of defined work packages, ensuring delivery from initiation through to completion. High level of autonomy, with the ability to work largely independently while maintaining alignment with overall project objectives. Proactive stakeholder engagement, ensuring appropriate involvement and close collaboration

📌 Assoc Mgr Clin Operations (Mumbai)
🏢 Thermo Fisher Scientific
📍 Mumbai