Provide multidisciplinary clinical, scientific, and technical subject matter expertise for a diverse portfolio of preclinical, clinical, and translational research projects (Therapeutic Areas: Oncology, Neurology, and Rare Diseases)Responsible for end-to-end project management, administrative, and operational support for complex multi-institutional research projects and single- and multi-site clinical trials.Perform data search, integration, curation, analysis, and visualization using real-world data sources to generate analysis-ready datasets and real-world evidence.Oversee and provide abstraction, registry management, data management, and quality improvement for single- and multi-site clinical trials, research projects, and disease-specific cancer registries. Engage with key opinion leaders and cross-functional partners at academic institutions, consortia, life science sponsors, and regulatory agencies to understand business needs and translate them into actionable strategies, projects, and operational objectives. Collaborate with investigators and stakeholders to perform literature reviews, conduct data analysis, and develop study protocols, manuscripts, abstracts, presentations, and regulatory and technical documentation for investigator-initiated trials (IITs), lab-based studies, observational research projects, and programmatic efforts.Contribute to negotiating, preparing, amending, and executing scientific research agreements. Understand and ensure compliance with study protocols, regulatory guidelines, research best practices, and industry standards.

Perform analytical and longitudinal clinical data abstraction (CDA) of patients with primary and secondary brain tumors using Real-World Data (RWD) sources and comprehensively code patient data into disease-specific tumor registries and institutional research databasesEngaged in clinical research trial implementation by conducting study-related activities while ensuring patient safety, regulatory, institutional, ICH-GCP guidelines complianceDeveloped a technical manual of standard operating procedures (SOP) for CDA and Data Management that comprehensively addresses the research study data lifecycleDeveloped and implemented clinical research workflows, SOPs, and data management best practices for two clinical validation studies designed to measure patient-reported outcomes using telemedicine and wearable health technology in patients with primary brain tumorsExperience with writing, editing, and submitting research study protocols for IRB approval. Co-authored and published original research in scientific journals. Presented research findings at scientific meetings

Collaborated with the study team to plan study operations and conduct day-to-day research activities in compliance with ICH-GCP guidelines and regulatory requirements outlined by study protocols for seven Phase 2 and 3 clinical trials Routinely communicated and coordinated study activities with study participants, study teams, and other relevant stakeholders (i.e., Primary Investigators, IRBs, study sponsors, Contract Research Organization representatives, and vendors) Screened, recruited, obtained informed consent, and monitored the health status of study participants Independently and safely performed clinical tasks outlined by the study protocol with oversight from the Principal Investigators Completed data management tasks such as data collection, maintenance of source documents, completion of CRF, adverse events reporting, and other relevant study documentation