Assoc Mgr Clin Operations (eTMF)

**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 document...