• Analyze permit submission comments and rejection patterns to identify the most common causes of delays and opportunities to improve review cycle times. • Build, maintain, and refine NLP pipelines that classify reviewer comments into meaningful topics using clustering techniques and LLM-based approaches. • Design, test, and optimize prompts for Azure OpenAI and other AI models to classify, summarize, and extract insights from unstructured text. • Develop metrics, dashboards, and reports that translate data analysis into actionable recommendations for internal and external stakeholders. • Write and optimize SQL queries and Python-based ETL processes to extract, transform, and load data from SQL Server and cloud-based storage environments. • Evaluate AI and machine learning model outputs for quality, accuracy, consistency, and appropriate handling of sensitive information. • Design and execute experiments to measure and improve the effectiveness of classification models, prompts, and analytical approaches. • Partner with cross-functional teams to support data-driven decision-making and continuous improvement initiatives.

• Responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects • Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s) • Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing • May perform quality control of data entry • Provide input, assess and manage timelines • May develop CRF specifications from the clinical study protocol • Conduct database build UAT and maintain quality controlled database build documentation • Responsible for creating, revising, appropriate versioning and maintaining data management documentation • Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed • Review and query clinical trial data according to the Data Management Plan • Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM • Run patient and study level status and metric reporting • Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency • Coordinate SAE/AE reconciliation • Liaise with third-party vendors such as external data and EDC vendors • Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies • Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities • Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues

• The Clinical Data Manager II/Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. • Supervise project data entry process including development of data entry guidelines, training, data entry quality, and resourcing. • Ensure clinical data management deadlines are met with quality. • Conduct database build UAT and maintain quality controlled database build documentation. • Provide input, assess and manage timelines. • Review and query clinical trial data according to the Data Management Plan. • Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders.

• Responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. • Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. • Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing • Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. • Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database. • Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File. • Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed. • Review and query clinical trial data according to the Data Management Plan. • Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM. • Liaises with third-party vendors such as external data and EDC vendors in a project manager capacity in support of timelines and data-related deliverables. • Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders.