Senior Director, ( MD) Global Development Lead, Early Development
Pfizer
Job Level
Mid-LevelSenior
About the role
- Serve as a Clinical Data Reviewer and identify any errors in data by performing data review that require further clarification with the study sites
- Perform ongoing review of clinical/medical aspects of assigned patient data and documents
- Communicates any data training needs for CRAs, sites, etc
- Conduct in-stream data trend analysis in support of data quality and integrity (includes protocol compliance and targeted review of patient data)
- Provide clinical data Project Management and be viewed as an expert in clinical/medical review and cleaning
- Ensure data quality focus to audit readiness with Clinical Compliance and Systems Validation
- May assist in review and contribute to data capture requirements guidance in line with protocol and reporting requirements
- May be closely involved in data review and identification of readiness for clinical narratives for CSRs
- May participate in clinical data review meetings such as Protocol Deviation review, Data Review and Quality Team (DRQT), Statistical Review of Clinical Data (SRCD), Safety Monitoring Team (SMT) review
- Prepare slides of top-line results as required
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 writing 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 skills
- Project management skills
- Knowledge of Good Clinical Practice
- Comprehensive knowledge of clinical trial design
- Understanding of the overall drug development process
- Must work East coast hours
