### **TMF Specialist | Chennai**
**Job ID:** JR125795 | **Company:** ICON plc | **Category:** Regulatory Document Management | **Location:** Chennai (Office-Based)
#### **About ICON plc**
ICON plc is a global leader in **healthcare intelligence and clinical research**. We foster an **inclusive and innovative** work culture, driving excellence in **clinical development**. Join us in ensuring **effective Trial Master File (TMF) management**, supporting transparency and compliance in clinical research.
📍 **Location:** Chennai (Office-Based)
### **Role Overview**
As a **TMF Specialist**, you will manage **electronic Trial Master File (eTMF) activities** across all phases of a clinical trial, ensuring compliance with **regulatory standards** and company guidelines. You will work closely with **clinical trial teams and CRO staff** to maintain TMF quality and support audit readiness.
### **Key Responsibilities**
- Maintain effective communication with **clinical trial teams and CRO staff** throughout the trial lifecycle.
- Manage **Quality Issues (QIs)** for assigned trials, ensuring timely resolution of TMF quality control findings.
- Oversee **Expected Document Lists (EDLs)** and escalate non-compliance to the **eTMF Manager**.
- Provide **ad-hoc reports and metrics** on TMF health for internal teams.
- Support **document filing, quality checks, and compliance** in the Moderna eTMF system.
- Maintain a **naming and filing guide** for TMF documents.
- Respond to inquiries related to **TMF management and document content**.
- Assist in **inspection/audit preparation and remediation activities**.
- Keep up-to-date with **TMF Reference Model, industry best practices, and regulatory requirements**.
- Perform **general administrative tasks** related to assigned trials.
### **Who You Are**
#### **Required Qualifications**
- **Bachelor’s degree** (preferably in Science or Healthcare).
- **1+ years of experience** in **eTMF document management** (clinical trial experience is a plus).
- Strong **organizational and prioritization skills** with **attention to detail**.
- Basic knowledge of **DIA TMF Reference Model** is an advantage.
### **Why Join ICON?**
At **ICON**, we value our people and offer:
✅ **Competitive salary and benefits**.
✅ **Annual leave entitlements**.
✅ **Comprehensive health insurance** for employees and families.
✅ **Retirement planning options** for financial security.
✅ **Global Employee Assistance Programme** for 24/7 well-being support.
✅ **Work-life balance perks**, including gym memberships, travel subsidies, and more.
✅ **A diverse, inclusive, and innovative work culture**.
🌎 **Apply now and be part of ICON’s mission to advance clinical research through transparency and compliance!**
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