Company Overview:
Parexel is a global leader in biopharmaceutical services, specializing in clinical research, consulting, and informatics. Join us to advance medical research and improve patient health.
Position: Senior Clinical Data Analyst
Organization: Parexel
Location: Hyderabad, Bangalore
Experience: 1 to 2 Years
Qualification: B.Pharm, M.Pharm, Pharm.D, M.Sc, B.Sc, Lifesciences
Salary: Not disclosed
Role Highlights:
Key Responsibilities:
| Responsibility | Details |
|---|---|
| Data Validation (Cleaning) | Lead data validation, manage queries, review listings, reconcile external vendor data |
| Data Management Documents/Plans | Ensure documentation as per SOPs, ICH/GCP Guidelines |
| Study Start-Up & UAT | Perform UAT, review protocols and EDC Entry Screens, coordinate DM activities |
| Data Tracking and Entry | Track CRFs, support data entry |
| Project Quality Management | Ensure compliance with SOPs, perform QC activities |
| Training | Maintain training compliance, mentor team, act as Subject Matter Expert |
| Process/Project Improvement | Develop tools for improved efficiencies |
| Project Finance & Resource Support | Manage project financials, address scope changes |
Skills Required:
- Leadership & collaboration with global teams
- Task coordination & prioritization
- Negotiation & problem-solving
- Commitment to quality & analytical approach
- Communication & presentation skills
- Learning ability & knowledge sharing
- Flexibility & accountability
Knowledge and Experience:
- Advanced Microsoft Office proficiency
- Data management & validation expertise
- Understanding of ICH-GCP Guidelines and Parexel SOPs
- Knowledge of Clinical Data Management Systems (e.g., InForm, Rave)
- Experience in clinical research
- Familiarity with medical terminology & coding dictionaries
- Basic SAS & CDISC standards knowledge
- Financial principles for DM project management
- Leading global Data Management teams
