Clinical Data Analyst II
Bengaluru, Karnātaka, India Additional Locations: India, Hyderabad; India, Remote 职位编号 R0000045515 类别 Data Management关于这个职位
Clinical Data Analyst II
Job Summary
We are looking for a detail-oriented Clinical Data Analyst II to support clinical trial data management activities. The successful candidate will be responsible for managing, analyzing, and validating clinical trial data to support regulatory submissions and clinical research objectives. This role requires strong technical skills, attention to detail, and the ability to work independently while collaborating with cross-functional teams and study start-up support while ensuring compliance with ICH-GCP guidelines and industry standards.
Key Responsibilities
- Perform clinical data validation: Extract, clean, validate, and reconcile clinical trial data from various sources.
- Manage data queries and support database lock activities.
- Review manual and system-generated data listings to identify discrepancies and ensure data quality. Identify and resolve data inconsistencies.
- Support the preparation and maintenance of Data Management documents and study-related records.
- Conduct User Acceptance Testing (UAT) for clinical database setups.
- Review study protocols, CRFs, and EDC screens when required.
- Track CRFs and support data entry activities as needed.
- Ensure adherence to SOPs, regulatory requirements, and ICH-GCP guidelines.
- Collaborate with cross-functional study teams and client stakeholders.
- Mentor junior data analysts and contribute to process improvement initiatives.
Required Skills
- Strong analytical and problem-solving abilities.
- Excellent attention to detail and commitment to quality.
- Strong verbal and written communication skills.
- Effective time management and prioritization skills.
- Ability to collaborate within cross-functional teams.
- Adaptability and willingness to learn new technologies and processes.
Technical Requirements
- Experience with Clinical Data Management Systems such as Medidata Rave, Veeva, DataLabs, ClinBase or others.
- Understanding of clinical data management processes, including data cleaning and database lock activities.
- Knowledge of MedDRA and WHODrug coding dictionaries.
- Basic knowledge of SAS and CDISC standards.
- Good understanding of ICH-GCP guidelines and clinical research regulations.
Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Nursing, or a related discipline.
- Relevant experience in Clinical Data Management or the Clinical Research industry.
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