SUMMARY

• 6+ years of Clinical Data Management Experience working as Data analyst/Business Analyst, expertly gathering and analyzing data for highly confidential clinical trials.
• Proficient in defining and validating protocols for clinical studiesand handling trial responsibility throughout the data - management lifecycle.
• Advanced skills in EDC systems, expert in database design and study hypothesis, well-versed in cGCP and FDA standards and regulations, and knowledgeable in therapeutic indications.
• Experienced clinical research professional. Detail oriented and Client focused approach to work.
• Provided my acquired skills in clinical research to many branches of the Health Science industries.
• Record of success in managing clinical operational tasks and executing deliverables for valued pharmaceutical clients.
• Flexible attitude with respect to work assignments and new learning.
• Two years of experience working with Clinical Research Organizations (CRO’S), gathering and analyzing data for highly confidential clinical trials.
• Quickly mastered industry best practices in CRO clinical-study procedures and data management.
• Excelled in managing high-priority projects and resolving data discrepancies, errors and omissions with thoroughness and expedience.
• Proficient in defining protocols for clinical studies and handling trial responsibility throughout the data management life cycle.
• Ability to manage multiple and varied tasks with enthusiasm and attention to detail.

TECHNICAL SKILLS

Business Skills: Business Definition Requirements, Business Process Analysis, Gap Analysis, Use Case Modeling & Analysis

Operating Systems: Windows 95/98/XP/2000/2003

DBMS: Oracle

Data Planning: Defining Programs, Organization Units, Regions and Studies.

Data Design: Creating Intervals, Events and Patient positions.

Clinical Application: Oracle Clinical

MS Office Software: MS OFFICE Suite (Word, excel, PowerPoint, Visio, Project)

Languages: HTML, Basic SQL

PROFESSIONAL EXPERIENCE

Confidential, Chicago, IL

Sr. Clinical Data Analyst/ System Analyst

Responsibilities:

• Involved in meetings to understand the in scope systems for cycles based on different regions.
• Research, collect and assemble data to prepare databases as per the requirements
• Responsible for clinical data review, edit check review and data clarifications on complex projects
• Support clinical trials for CRO by providing meticulous data management.
• Design and maintain databases, queries, reports, graphics and data-analysis tools; perform data entry, check reviews, database audits and coding; and define and validate study protocols.
• Work closely with Oracle Clinical developers on the design, testing and implementation of study databases.
• Oversee data-management lifecycle of large clinical trials, composing and verifying reports and results.
• Develop clear clinical data sets enabling the standardized collection and analysis of massive amounts of cross-boundary data content in a timely manner and with a high level of accuracy.
• Facilitated the rollout of new EDC system that streamlined data entry and improved data-analysis functions. Contributed to design and development of new GUIs, validation components and reporting tools.
• Prepare forms for data entry as determined by review guidelines and standard department procedures. Document, resolve and integrate data queries.
• Track progress of clinical studies, ensuring projects meet timelines and quality expectations.
• Writing programs for analysis datasets (ADs) based on the Statistical Analysis Plan
• Creating programs for tables, figures and listings for the Clinical Study Report (CSR)

Confidential - Valencia, CA

Data Analyst / Systems Analyst

Responsibilities:

• Obtained input from clinical team for clinical data management issues.
• Generated reports for Clinical Events and Protocol Deviations for Regulatory Affairs.
• Perform data review and query generation.
• Define edit checks to be programmed for the study/projects.
• Track study progress and issue periodic status reports.
• Participated consistently in complaint investigations, corrective and preventative actions.
• Reviewed data effectively for completeness and inconsistencies.
• Issued and managed clinical data queries to closure.
• Identified process improvements for clinical data collection.
• Implemented Agile methodology by using techniques such as Joint Application Development (JAD) sessions.
• Closely involved with improving strategies and workflow using Agile methodology.
• Participated in Project Management activities such as version releases and preparing project schedules.
• Assisted in developing project timelines list of deliverable and developed strategies for effective project management.
• Created a Business Requirement Document (BRD) and Functional Requirement Document (FRD) according to minute meetings gathered during JAD sessions and interviews.
• Generated Use Case Documents and UML Diagrams such as Data Flow Diagrams and Use Case Diagrams using MS Visio.
• Assisted in the creation of database objects such as Tables, Stored Procedures, Views and Triggers by writing queries and joins.
• Reviewed listings for Quality Control
• Reviewed documents and prepared a validation binder for all releases.
• Worked with Clients to obtain insight on the expectations and deliverables.

Confidential

Clinical Data Analyst

Responsibilities:

• Reviewed CRF’Sfor completeness, accuracy and consistency in accordance with applicable procedures.
• Defined edit checks for the study/project.
• Performed datacoordination activities anddatavalidation on CDM projects.
• Assisted User Acceptance Testing before Go-live. Activities included enrolling subjects, collecting feedback and facilitate re-testing of failed scripts.
• Identified and addresseddatadiscrepancies in theclinicaldatavia computerized edits and manual checks/listings.
• Performed Discrepancy Management including manual and system query generation, sending queries to the sites, reviewing and closing the answered queries.