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Senior Specialist Clinical Trial Transparency

5+ years
Not Disclosed
10 Feb. 12, 2025
Job Description
Job Type: Full Time Education: BS/BA 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

### **Senior Specialist - Clinical Trial Transparency | Bangalore, India**  
**Job ID:** 284200 | **Location:** Bangalore, Karnataka | **Job Type:** Full-time | **Work Mode:** Hybrid  

#### **Work Your Magic with Us!**  
Join a **global leader in Healthcare, Life Science, and Electronics**, where you will play a key role in **clinical trial transparency (CTT)** by ensuring **compliance, risk management, and document transparency**.  

### **Your Responsibilities**  
- **Document Transparency & Compliance**  
  - Lead and participate in **redaction of clinical trial documents** (e.g., **protocols, CSR**).  
  - Develop and distribute **lay language summaries, manuals, and CTT documents**.  
  - Oversee and deliver **CAPAs** to maintain compliance standards and timelines.  
- **Operations & Oversight**  
  - Support **risk and issue management** processes in clinical trials.  
  - Assist with **vendor oversight**, including document review and invoice management.  
  - Help study teams **prepare for audits/inspections**.  
  - Create, update, and maintain **trackers, dashboards, and reports** for metric reporting.  
- **Stakeholder & Project Management**  
  - Represent **CTT within the Global Trial Team** as an operational contact.  
  - Contribute to the development of **SOPs, processes, and department initiatives**.  
  - Execute **CTT deliverables**, including defining milestones and project scope.  

### **Who You Are**  
- **Education & Experience:**  
  - **BS/BA in Life Sciences or Healthcare-related field**.  
  - **5+ years of experience in clinical research** (CRO, study site, or Pharma/Biotech industry).  
  - **4+ years of experience in clinical trial transparency**.  
- **Skills & Competencies:**  
  - Strong understanding of **clinical development, global registries (ClinicalTrials.gov, CTIS, etc.), and Pharma CM electronic disclosure systems**.  
  - **Leadership & influencing skills** with effective communication.  
  - Ability to foster **cross-functional partnerships** and work in **multidisciplinary teams**.  
  - Basic knowledge of the **drug development process and regulatory frameworks**.  

### **What We Offer**  
A **dynamic, diverse, and inclusive environment** where **innovation, excellence, and career growth** are encouraged.  

🚀 **Apply now and become part of a team shaping the future of clinical trial transparency!**  

**Slug:** senior-specialist-clinical-trial-transparency-bangalore