• Leading clinical data management activities for clinical trials, ensuring accurate and complete collection, validation, and reporting of study data using SAS.
• Collaborating closely with cross-functional teams, including CRAs, medical monitors, and statisticians, to establish data collection requirements and ensure data quality using SAS.
• Designing and developing Case Report Forms (CRFs) in collaboration with clinical teams, enabling efficient and accurate data collection.
• Implementing Electronic Data Capture (EDC) systems, such as [Oracle Health Sciences Inform], to streamline data collection and analysis processes.
• Conducting data validations and resolving discrepancies through effective query management, contributing to high-quality and reliable study data.
• Ensuring compliance with regulatory standards (ICH-GCP) and company SOPs throughout the data management lifecycle.
• Supporting the development of study protocols by providing input on data management considerati

• Assisted in clinical trials were performing informed consent process, recruiting subjects, interacting with patients and ensured compliance to protocols and standard procedures.
• Prepared and submitted regulatory documents to regulatory authorities.
• Designed and Reviewed patients CRFs and questionnaires for research work.
• Reviewed and ensured completion of necessary documentation and prepared case reports and coordinated with various patients.
• Created edit checks, data validations, and query writing.
• Knowledge of 21CFR Part 11, Good Clinical Data Management Practice (GCDMP).
• Trained in SAE reconciliation Third party data reconciliation.
• Lock and Freeze
• UAT Testing
• Using SAS to generate reports of clinical data during clinical research.

• Led daily scrum meetings, sprint planning, reviews, and retrospectives, guiding multiple Onshore and Offshore Scrum teams in agile best practices.
• Collaborated closely with Product Owners to groom and maintain product backlogs, ensuring sprint-ready user stories.
• Coordinated efforts between engineering, design/UX, and marketing stakeholders, ensuring seamless cross-functional collaboration.
• Worked with Agile Release Train Engineer to define and refine program and team backlogs, facilitating PI planning activities.
• Orchestrated User Story Interdependency meetings across multiple scrum teams, ensuring alignment with delivery schedules.
• Cultivated a safe environment for open communication, fostering problem-solving and healing within the team.
• Tracked team-level progress and quality metrics, providing transparency to stakeholders.
• Guided an Agile/Scrum transformation for a team developing a mobile application.
• Coached both Scrum Team and Development team on self-

• Developed and Executed Strategic Project Plans: Formulated comprehensive project plans that delineated clear goals, strategies, resource allocations, staffing requirements, risk assessments, and contingency measures, ensuring a systematic approach to project execution.
● • User-Centric Focus and Outcome Development: Assumed responsibility for comprehending user expectations, processes, and requisite inputs/outputs essential for defining specific functionality and desired outcomes. Employed this insight to shape the project direction effectively.
● • Leadership and Execution: Spearheaded the meticulous execution of tasks stipulated in the project plan, steering cross-functional teams toward the attainment of project objectives. Led by example, motivating team members to achieve project goals.
● • Change Management and Scope Control: Managed modifications to project scope, schedule, and budget through diligent verification techniques. Ensured that the project plan remained precise,

• Utilized Geographical Information System (GIS) to generate a spatial representation of flood-affected areas, aiding in understanding the impact on housing flood elevations.
• Conducted Hedonic Regression analysis using Statistical Package for the Social Sciences (SPSS) to assess changes in structural housing prices and value post-flooding in Harris County.

• Assisted the PM in Keeping Track of the Project Budget in an excel spreadsheet.
• Reported to managers on the development of the project.
• Tracked Project milestones, Schedule, and Deliverables
• Managed changes and ensured effective communication among project team members.
• Organized and maintained project team SharePoint site, ensuring required documentation is posted for team member access.
• Facilitated project planning and scheduling across individual projects.