Medical Data Reviewer

Clinical Data Review:

• Review clinical/medical aspects of patient data and documents, including eligibility, diagnosis, medical history, treatments, adverse events, concomitant medications, safety labs, and efficacy assessments.
• Issue clinical data queries and ensure timely follow-up on responses from study sites.
• Conduct ongoing data trend analysis to support data quality and integrity.
• Provide expertise in data clinical/medical review and cleaning.

Project Management:

• Manage clinical data projects and ensure compliance with protocols and reporting requirements.
• Monitor site data entry performance and identify root causes of data issues.

Communication and Collaboration:

• Communicate data training needs to relevant stakeholders.
• Collaborate with Clinical Scientists, Medical Directors, Data Management, and Clinical Operations to execute clinical data reviews and activities.
• Participate in various clinical data review meetings and prepare materials for data dissemination meetings.

Quality Assurance and Improvement:

• Ensure audit readiness and compliance with clinical and systems validation.
• Continuously assess opportunities to improve efficiency and quality of data deliverables.

Documentation and Reporting:

• Contribute to the preparation and review of clinical data sections for abstracts, manuscripts, presentations, and clinical study reports.

Required Experience and Skills:

• Educational background in MD, PharmD, PhD, Nursing, or MSc.
• Minimum 5 years of pharmaceutical clinical/medical data review experience, preferably 8+ years.
• Experience in Solid Tumor Oncology.
• Strong verbal and written communication skills in English.
• Detail-oriented with strong organizational and tracking skills.
• Experience in coding review and query writing.
• Proficiency in clinical database navigation, MS Excel, and project management.
• Ability to work independently and collaboratively in a team setting.
• Knowledge of Good Clinical Practice and clinical trial design.