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Manager - Clinical Trial Transparency

5+ years
Not Disclosed
10 Feb. 12, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

### **Manager - Clinical Trial Transparency | Bangalore**  
**Job ID:** JR127460 | **Company:** ICON plc | **Category:** Medical Writing | **Location:** Bangalore (Office-Based)  

#### **About ICON plc**  
ICON plc is a global leader in **healthcare intelligence and clinical research**. We foster an **inclusive and innovative** environment, driving excellence in clinical development. Join us in ensuring **transparency and compliance** in clinical trials, shaping the future of ethical research.  

### **Role Overview**  
As a **Manager, Clinical Trial Transparency**, you will play a key role in ensuring compliance with regulatory requirements for **clinical trial data disclosure**. You will oversee **anonymization and redaction** processes, coordinate cross-functional teams, and manage vendor interactions while contributing to the **advancement of innovative therapies**.  

📍 **Location:** Bangalore (Office-Based)  

### **Key Responsibilities**  
- Lead **redaction/anonymization** activities for clinical documents as per regulatory guidelines.  
- Develop and maintain the **commercial confidential information (CCI) strategy** in collaboration with content experts.  
- Organize **kick-off meetings** and train relevant teams on clinical data transparency processes.  
- Coordinate **cross-functional teams**, manage timelines, and track project progress.  
- Ensure compliance with **local laws and global regulatory authority guidelines**.  
- Manage vendor interactions and provide **document management expertise**.  
- Interface with **health authorities** alongside sponsor regulatory teams (e.g., Health Canada PRCI PIM Meeting).  
- Train and mentor new colleagues as required.  

### **Who You Are**  
#### **Required Qualifications**  
- **Bachelor’s degree** (advanced degree preferred).  
- **5+ years of experience** in the **pharmaceutical industry**.  
- Strong **English communication skills** (written and verbal).  
- Experience in **electronic document management, IT tools, and redaction/anonymization platforms**.  
- **Project management, process development, and coordination experience**.  
- Ability to collaborate across **hierarchical levels** and work **independently** with precision.  
- **Vendor management experience** is a plus.  

### **Why Join ICON?**  
At **ICON**, we value our people and offer:  
✅ **Competitive salary and benefits**.  
✅ **Flexible annual leave policies**.  
✅ **Comprehensive health insurance** plans for employees and families.  
✅ **Retirement planning** for financial stability.  
✅ **Global Employee Assistance Programme** for 24/7 well-being support.  
✅ **Work-life balance perks**, including childcare vouchers, gym memberships, travel subsidies, and more.  
✅ **A diverse, inclusive, and innovative work culture**.  

🌎 **Apply now and be a part of ICON’s mission to drive ethical clinical research!**