Professional Areas of Interest

• Strategic Planning
• Quality Improvement
• Clinical Research
• Data Management
• Regulatory Compliance
• Quality Assurance
• Telemedicine

Professional Experience

Application Specialist III

• Manages Clinical Databases including data management and process flow
• Builds and Manages Research Databases
• Develops and manages data management plans for Data Management needs
• Provides work direction to team members in support of data management and divisional initiatives.
• Establishes and oversees data review cycles for critical Clinical and Research projects
• Organizes meeting structure with project teams and plans and facilitates internal team meetings
• Develops processes and procedures related to divisional EPIC needs
• Trains and mentors team members about data management approaches and tools
• Manages project Quality Assurance and Audit activities
• Manages system Quality Assurance and Audit activities
• Participates in improving divisional performance through recommending areas or approaches for improvement activities, performing new procedures, collecting data and providing input to department discussions.
• Prepares documents to support data management and reporting needs
• Prepares documents to support new system builds
• Designs and executes test plans for new system builds
• Coordinates collection of data from project team members and other sources.
• Serves as divisional Data Manager and consultant in the design and implementation of departmental clinical and research information systems.
• Evaluates departmental training needs and develops training strategies, standards and objectives.
• Participates in organizational Standard Operating Procedures development
• Participates in organizational data management initiatives and trainings
• Participates in divisional quality improvement initiatives and reporting
• Participates in divisional strategic planning initiative development
• Liaison between division and Bioinformatics for new system builds
• Conducts clinical data audits to clean and validate EPIC DocFlowSheet data
• Develops clinical and research reports using Business Objects Web Intelligence and Crystal reports for teams using EPIC Clarity tables and ICD9 and ICD10 Codes
• Assist with the design of Case Report Forms
• Designs Research Databases in REDCap
• Develops Data Management Plans for Research Studies
• Develops data quality checks and edits for data validation plans
• Develops and executes test plans for research studies in accordance to data management SOP's
• Creates annotated CRF's to assist statisticians with data analysis
• Support all data management clinical and research needs
• Conducts research data audits to clean and validate research study data for DSMB reporting

Confidential

Application Specialist II

• Managed Clinical Databases including data management and process flow
• Developed and managed project plans for Data Management needs, including work plan and resource allocation
• Provided work direction to team members in support of data management and divisional initiatives.
• Established and oversaw data review cycles for critical Clinical projects
• Organized meeting structure with project teams and plans and facilitates internal team meetings
• Developed processes and procedures related to divisional projects. Initiates and communicates changes as necessary.
• Trained and mentored team members about data management approaches and tools
• Managed project Quality Assurance and Audit activities.
• Participated in improving divisional performance through recommending areas or approaches for improvement activities, performing new procedures, collecting data and provided input to department discussions.
• Prepared documents to support data management and reporting. needs
• Coordinated collection of data from project team members and other sources.
• Served as divisional project manager or consultant in the design and implementation of departmental information systems.
• Evaluated departmental training needs and developed training strategies, standards and objectives.
• Participated in organizational SOP development
• Managed training and provided support for EPIC GO LIVE for division
• Developed mapping documents for new clinical systems to EPIC

Confidential

Clinical Data Analyst

• Performed the tasks of higher level data management activities such as database design and setup, independent review of CDM deliverables, Medical Coding. Provided Data Management support for clinical trial databases such as:
• Initial Discrepancy reviews
• Discrepancy closeouts
• All levels of data QC
• Database Listing Reviews
• Data Validation Manual creation
• Participated in PQP meetings

Confidential

Data Management Analyst

• Coordinated the development of data management system solutions for use in worldwide clinical trials.
• Managed tight deadlines for designing, developing and coding systems solutions within the designated data management tool s .
• Participated in Study Development Process SDP meetings as indicated
• Designed and developed data management system solutions using the standard reference library.
• Liaised with study team members to determine and confirm study set-up specifications.
• Reviewed selected panels and rules for design and usability to prevent storage, reporting or standards issues.
• Resolved trouble tickets and change requests generated by customers.
• Tested and validated all system solutions.
• Improved study set-up to increase data accuracy and decrease data capture and cleaning time.
• Tracked, reviewed and identified improvements in metrics.
• Wrote and implemented business procedures as needed.
• Proactively provided guidance at meetings regarding study set-up processes and timelines.
• Provided study set-up expertise on cross-functional committees.
• Coordinated with the Data Collection Coordinator DCC , Clinical Data Management Coordinator CDMC and others on the migration and validation of eCRFs.
• Ensured compliance with data standards as appropriate.
• Reformatted and updated forms, panels and rules in Clintrial as needed.

Confidential

Clinical Data Programmer I

• Functioned as a department representative on Kendle project teams.
• Established/negotiated timelines and ensured that project milestones were met.
• Reviewed case report forms CRFs and ensured the design supported a high quality database.
• Reviewed data for adherence to protocol, consistency in handling and coding, consistency in investigators' interpretations of CRFs, and completeness, accuracy, and appropriateness of final database.
• Developed specifications for CRF data sets, and specifications and mock-up displays for routine listings, tables and figures.
• Built, tested and validated clinical databases, received and processed external data, and programmed and validated data sets, tables, listings, and figures.
• Coordinated, created and maintained project documentation.
• Participated in the mentoring of personnel.

Clinical Programmer / Analyst

Processed data from sponsors, including study database set-up, application of edits, data transfer, data cleaning, database mapping, computer file management, and reporting and documentation for Phase I through IV Studies in adherence to all applicable regulatory guidelines and SOPs.

Analyzed, wrote, tested, ran and maintained computer programs for the import of data from external sources into the clinical database system.

Regulatory Assistant Contract

• Composed and typed complex and confidential correspondence.
• Initiated required administrative reports.
• Assisted in developing, implementing, and monitoring internal operating systems and procedures.
• Typed tables, charts, memorandums, and reports.
• Set up and maintained alphabetical, numerical, and subject filings system.
• Collected information and made personal contacts to obtain information in order to prepare detailed reports and compose routine correspondence.
• Answered the phones
• RESEARCH INDUSTRY SKILLS
• ICH Guidelines for Good Clinical Practice
• 21 CFR Part 11: General Overview
• 21 CFR Part 11: Subpart A: General Provisions
• 21 CFR Part 11: Subpart B: Electronic Records
• 21 CFR Part 11: Subpart C: Electronic Signatures
• Good Documentation Practices

RESEARCH CERTIFICATION COURSES

• The Drug Development Process
• Regulations in Clinical Trials
• Clinical Outcomes and Measures
• Computer Experience
• Operating Systems: Windows, Windows NT, MS-DOS
• Programming Languages: SAS, Visual Basic, Crystal Reports, SQL, Business Objects
• Databases / DB Tools: TrialWare, Clintrial Version 3.1.1, Oracle Clinical Version 4.01 and Version 4.03, Query Direct, SQL Server 7.0, MS Access, SQL, DB2, Oracle, REDCap, i2b2
• Internet Technologies: HTML
• Other Packages: MS Word, WordPerfect, MS PowerPoint, MS Excel, MS Project, MS One Note, Photoshop, Visio, SharePoint, MS Publisher, MS InfoPath
• Clinical Software: DocSite, EPIC, Tempus, KIDS, ICIS
• EPIC Experience: Clarity Reports, EpicCare Ambulatory, Inpatient, ADT/Prelude, Cadence, Charge Router, Abstractions, Flowsheets, In basket, Mychart, Order Sets, Preference Lists, Smart Sets, Work Flow