Major Accountabilities:
- Ensure high-quality clinical trial data review, insights, and analysis as directed by the Integrated Clinical Trial Team (iCTT).
- Perform clinical data review, identify clinical data insights through patient-level review and trend analysis, and support Interim Analysis, Database, and Post Lock activities.
- Facilitate resolution of clinical data issues, collaborating with relevant line functions to enhance data review quality, emphasizing subject safety and eligibility, data integrity, trend identification, and analysis.
- Contribute to the development of Data Review/Quality Plans (DRP/DQP) and data review strategies, ensuring consistent implementation of protocol-level deviations, eligibility criteria, study assessments, and other protocol aspects.
- May contribute to Case Report Form (CRF) development and support data capture tool implementation.
- Facilitate data review process improvements and identify delinquent/redundant reports and/or implement innovative data analysis processes and tools.
- Contribute to the development of study-level documents, including clinical sections of key regulatory documents (Investigator’s Brochures, briefing books, safety updates, submission dossiers).
- Review/write clinical trial documents for study CSR activities and publications in collaboration with relevant line functions.
- Support pharmacovigilance activities, including reviewing/contributing to aggregate reports/patient narratives and attending Safety Monitoring Meetings (SMT), if required.
- Produce training materials and provide training to iCTT.
