
Position Summary Parexel, a leading global clinical research organization (CRO), is seeking a detail-oriented Clinical Data Analyst II to join its clinical trial data management team (Job ID: R0000045515). The successful candidate will play a crucial role in managing, analyzing, and validating clinical trial data to ensure regulatory compliance and the achievement of research objectives.
Position Details
| Detail | Specification |
| Position Title | Clinical Data Analyst II |
| Department | Clinical Data Management |
| Global Institution | Parexel International (CRO) |
| Primary Location | India, Bengaluru |
| Additional Locations | India, Hyderabad; India, Remote |
| Job ID | R0000045515 |
Key Responsibilities
- Data Validation & Integrity: Perform clinical trial data extraction, cleaning, and reconciliation from diverse sources; review system-generated and manual data listings to identify and resolve discrepancies.
- Database Operations: Manage data query workflows and support technical database lock activities in compliance with strict project timelines.
- Quality Assurance & Documents: Maintain crucial Data Management documentation and study records; participate in User Acceptance Testing (UAT) for clinical database setups.
- Collaboration & Leadership: Review study protocols and CRFs; collaborate effectively with cross-functional study teams and client stakeholders; mentor junior data analysts.
Qualifications & Experience
- Academic Background: A Bachelor’s degree in Life Sciences, Pharmacy (B.Pharm), Biotechnology, Nursing, or a relevant scientific discipline.
- Professional Experience: Relevant hand-on experience in Clinical Data Management (CDM) or within the core Clinical Research industry is mandatory.
Technical Competencies & Skills
- CDM Systems: Experience with Clinical Data Management Systems such as Medidata Rave, Veeva, DataLabs, or similar platforms.
- Regulatory Framework: Strong understanding of current ICH-GCP guidelines, clinical research regulations, and standard operating procedures (SOPs).
- Coding Dictionaries: Hands-on knowledge of using MedDRA and WHODrug coding dictionaries.
- Data Standards: Basic familiarity with SAS programming concepts and CDISC standards.
