As a Medical Data Reviewer, you will play a crucial role in ensuring the accuracy and integrity of clinical data. Your responsibilities will include performing data reviews, identifying errors, and ensuring compliance with clinical protocols.
Key Responsibilities:
- Serve as a Clinical Data Reviewer and identify errors in data requiring further clarification.
- Perform ongoing review of clinical/medical aspects of assigned patient data and documents.
- Issue clinical data queries and ensure timely follow-up to address queries appropriately.
- Communicate data training needs for CRAs and study sites.
- Conduct in-stream data trend analysis to support data quality and integrity.
- Provide clinical data project management and expert guidance in data review and cleaning.
- Ensure data quality focus for audit readiness with Clinical Compliance and Systems Validation Compliance.
- Assist in review and contribute to data capture requirements guidance in line with protocol and reporting requirements.
- Monitor site data entry performance and implement remedial actions for data issues.
- Participate in clinical data review meetings such as Protocol Deviation review, Data Review and Quality Team (DRQT), and Safety Monitoring Team (SMT) review.
- Prepare and review materials for data dissemination meetings and presentations.
- Collaborate closely with Client Clinical Scientists, Medical Directors, Data Management, and Clinical Operations for data review and activities.
Required Experience and Skill Set:
- Educational scientific background such as MD, PharmD, PhD, Nursing degree, MSc.
- ≥ 5 years of pharmaceutical clinical/medical data review experience is required; 8+ years is preferable.
- Experience with Solid Tumor Oncology.
- Excellent verbal and writing communication skills in English.
- Strong operational, organizational, and tracking skills with a demonstrated ability to meet timelines.
- Detail-oriented with experience in coding review and query writing training.
- Strong clinical database navigation skills and proficiency in MS Excel and project management.
- Ability to work independently and in a team setting.
- Knowledge of Good Clinical Practice and comprehensive knowledge of clinical trial design and drug development process.
