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.
