Parexel Hiring: Senior Clinical Data Analyst
About Parexel:
Parexel is a global biopharmaceutical services organization specializing in clinical research, consulting, and informatics. Join our team and contribute to improving patient health and advancing medical research.
Position: Senior Clinical Data Analyst
Organization: Parexel
Qualifications:
- B.Pharm, M.Pharm, Pharm.D, MSc, BSc, Lifesciences
Experience: 1 to 2 Years
Salary: Not disclosed
Location: Hyderabad, Bangalore
Responsibilities:
- Data Validation (Cleaning): Lead data validation activities, including query management, manual/SAS listing reviews, and external vendor data reconciliation.
- Data Management Documents/Plans (Trial Master File): Ensure proper documentation as per SOPs, ICH/GCP Guidelines.
- Study Start-Up Activities and User Acceptance Testing (UAT): Perform UAT on clinical database setups and review protocols.
- Data Tracking and Entry: Track and review CRFs and support data entry.
- Project Quality Management & Compliance: Ensure compliance with SOPs and ICH/GCP Guidelines.
- Training: Maintain training compliance and provide on-the-job training.
- Process/Project Improvement: Develop and implement project-specific tools.
- Project Finance & Resource Support: Provide input on scope changes and manage DM project financials.
Skills:
- Leadership and collaboration with global and cross-functional teams
- Task coordination and prioritization
- Negotiation, problem-solving, and logical reasoning
- Commitment to first-time quality
- Interpersonal, oral, and written communication
- Presentation skills
- Knowledge-sharing approach
- Flexibility with work assignments
- Accountability and innovation
Knowledge and Experience:
- Technical Aptitude: Microsoft Office Products
- Data Management Processes: Understanding of data validation flow
- Regulatory Guidelines: ICH-GCP, local regulatory requirements, Parexel SOPs
- Clinical Data Management Systems: InForm, Rave, Veeva, DataLabs, ClinBase
- Clinical Study Team Roles: Understanding of roles within Data Management
- Medical Terminology and Coding: MedDRA, WHODRUG
- Database Setup and Operational Processes: Experience with setup activities and operational processes
- SAS and Data Standards: Basic knowledge of SAS and CDISC
- Project Financials: Understanding of financial principles for managing DM project financials
- Experience: Leading virtual/global Data Management operational teams
How to Apply: