Clinical Data Analyst II

This is a fully remote position, open to applicants in India.

📋 Description

• Execute clinical data validation by extracting, cleaning, validating, and reconciling clinical trial data from diverse sources.

• Oversee data queries and assist in database lock procedures.

• Examine both manual and system-generated data listings to detect discrepancies and uphold data quality.

• Recognize and rectify data inconsistencies.

• Aid in the preparation and upkeep of Data Management documents and study-related records.

• Conduct User Acceptance Testing (UAT) for clinical database configurations.

• Review study protocols, CRFs, and EDC screens as necessary.

• Monitor CRFs and assist with data entry tasks as required.

• Guarantee compliance with SOPs, regulatory standards, and ICH-GCP guidelines.

• Collaborate with cross-functional study teams and client stakeholders.

• Mentor junior data analysts and engage in process enhancement initiatives.

• Assist with study start-up activities.

⛳️ Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Nursing, or a related field.

• Relevant experience in Clinical Data Management or the Clinical Research sector.

• Strong analytical and problem-solving skills.

• Exceptional attention to detail and a commitment to quality.

• Proficient verbal and written communication abilities.

• Effective time management and prioritization capabilities.

• Ability to work collaboratively within cross-functional teams.

• Adaptability and eagerness to learn new technologies and processes.

• Familiarity with Clinical Data Management Systems like Medidata Rave, Veeva, DataLabs, ClinBase, or others.

• Understanding of clinical data management processes, including data cleaning and database lock procedures.

• Knowledge of MedDRA and WHODrug coding dictionaries.

• Basic understanding of SAS and CDISC standards.

• Solid grasp of ICH-GCP guidelines and clinical research regulations.

🏝️ Benefits

• Comprehensive health benefits package.

• Opportunities for professional development and career advancement.

• Flexible work arrangements.

• Collaborative and supportive work environment.

• Employee wellness programs.