Senior Director, Investigator-Initiated Trials & Expanded Access Programs, Global Medical Affairs
BeOne Medicines
Google Cloud Platform
Job Level
Mid-LevelSenior
About the role
- Serve as a Clinical Data Reviewer and identify any errors in data by performing data review requiring clarification with study sites
- Perform ongoing review of clinical/medical aspects of assigned patient data and documents
- Communicate data training needs for CRAs and sites
- Conduct in-stream data trend analysis in support of data quality and integrity, including protocol compliance and targeted review of patient data
- Provide clinical data project management and act as an expert in clinical/medical review and cleaning
- Ensure data quality focus to audit readiness with Clinical Compliance and Systems Validation
- Assist in review and contribute to data capture requirements guidance in line with protocol and reporting requirements
- Be involved in data review and identification of readiness for clinical narratives for CSRs
- Participate in clinical data review meetings (Protocol Deviation review, Data Review and Quality Team, Statistical Review of Clinical Data, Safety Monitoring Team, slide preparation of top-line results)
Requirements
- Educational scientific background such as MD, PharmD, PhD, Nursing degree, MS
- ≥ 5 years of pharmaceutical clinical/medical data review experience (8+ years preferable)
- Clinical crosscheck experience
- Experience with Solid Tumor Oncology
- Excellent verbal and written communication in English
- Organization and tracking skills
- Strong operational skills and demonstrated ability to meet timelines
- Experience in coding review
- Query writing training
- Strong clinical database navigation skills
- Strong MS Excel and project management skills
- Knowledge of Good Clinical Practice (GCP)
- Comprehensive knowledge of clinical trial design and understanding of the overall drug development process
- Must work East coast hours
