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 with key stakeholders such as Process Owners.
* Structured, project-oriented working approach, following a “Plan–Do–Check”
mindset:

* * * Plan and manage activities

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