Sara Fedorchak

• Global Standards Leadership: Direct clinical trial database architecture for high-priority oncology studies, ensuring eCRF forms and non-eCRF data (Labs, Imaging) align with internal global standards.
• Data Mapping & Validation: Lead SQL-based query resolution and vendor data reconciliation; authored mapping specifications to ensure clinical data is SDTM-ready at the point of collection.
• Stakeholder Influence: Represent Data Management in cross-functional meetings to resolve issues negatively impacting library objects or study delivery timelines.
• Ensured data integrity through rigorous validation and quality checks.
• Managed data entry timelines, ensuring compliance with project deadlines.
• Analyzed clinical trial data to identify trends and discrepancies.

• System Lifecycle Management: Coordinated the design of diverse EDC systems (Medidata, Veeva Vault, and Medrio ), utilizing SDLC principles to build and test complex data validation checks.
• Documentation SME: Authored DMPs and CRF Completion Guidelines, ensuring all documentation reflected industry best practices and CDISC compliance.
• Mentorship: Exercised independent judgment in managing project resources and coaching junior staff on Medidata Rave design and edit check specifications.
• Led clinical data management initiatives ensuring compliance with regulatory standards.
• Streamlined data collection processes, enhancing efficiency across multiple clinical trials.
• Collaborated with cross-functional teams to define project requirements and timelines.
• Implemented quality control measures, ensuring accuracy and integrity of clinical data submissions.

• CDASH/SDTM Alignment: Acted as primary liaison to ensure global trial data collection adhered to CDISC standards from the protocol review stage through database lock.
• Library Development: Contributed to the creation of standardized eCRF modules, reducing database build times for global oncology programs.
• UAT Execution: Led validation and UAT for complex database migrations, ensuring adherence to FDA and CDISC requirements.
• Designed data collection processes to enhance accuracy in clinical trials.
• Managed database systems to ensure integrity and accessibility of clinical data.
• Analyzed clinical trial data for discrepancies, ensuring high-quality reporting standards.

• EDC Implementation: Led eCRF design and developed standardized training manuals for study staff on electronic data capture systems.
• Trend Analysis: Identified and resolved data discrepancies in large-scale clinical datasets with a high degree of accuracy.
• Collaborated with cross-functional teams to streamline data collection processes and enhance reporting efficiency.
• Implemented quality control measures to identify discrepancies and improve overall data quality.
• Supported the management of study databases, monitoring data integrity throughout the project lifecycle.
• Implemented data review and oversight on multiple clinical study phases.

Clinical Foundation: 16 years of procedural documentation and medical device experience, providing deep therapeutic insight into data interpretation and patient safety.