KEY SKILLS

• SQL
• SQL Server
• SQL Server Management Studio
• SAS
• Oracle/Oracle Clinical
• Unix/VMS
• Clinical and Non-Clinical Data Management
• Technical Project Management
• Data Analysis
• Creation/translation of technical specifications
• Edit specification creation and testing
• User acceptance testing
• Quality control activities
• Supervision of team of 10-12 employees
• Team building, training and mentoring
• Vendor management
• EDC/eCRF Design/Testing/Implementation
• Data Warehousing

PROFESSIONAL EXPERIENCE

Confidential

Senior Data Manager

• Responsible for daily oversight of activities as well as assistance in setting up priorities for a group of Data Technicians/Coordinators and Associate Data Managers 10-12 people total performing data clean-up and delivery activities.
• Provide detailed operational input into project planning, focusing on data specifications and data management concerns.
• Work directly with customers on definition and/or review of data specifications through test data transfer and approval.
• Manage scheduling of data transfers.
• Assist in defining database set-up and testing to ensure desired results can be achieved.
• Coordinate all processes required to produce accurate, confidential and retrievable clinical data.
• Mentor Associate Data Managers and Data Technicians/Coordinators.
• Coordinate dataset preparation process, including generation of datasets, quality control review of output, and resolution of queries from dataset recipients.
• Provide oversight for the group of Data Technicians/Coordinators by conducting regular status meetings to review daily workload and managing assignments.
• Assist Project Managers in maintaining compliant project files.
• Collaborate and coordinate with others departments in the design, documentation, testing and implementation of clinical data management systems and procedures, as well as clinical database review.
• Support implementation of technology-enabled processes, working in partnership with other internal groups.
• Develop and document data standards, specifications and procedures.
• Design and test data validation logic checks.

Confidential

Clinical Data Manager

• Act as the lead data management contact on multiple clinical trials.
• Manage and perform project tasks in accordance with project timelines.
• Develop and present protocol specific training sessions to Investigators, Study Coordinators and Clinical Research Associates CRA .
• Conduct new employee/contractor training, mentors Associate Clinical Data Managers or Clinical Data Coordinators, and coordinate work among team members.
• Manage CRF development.
• Perform edit specification creation, review, and testing.
• Create test data and perform database user acceptance testing.
• Develop and maintain report specifications.
• Write ad hoc queries based on data validation specifications.
• Responsible for reviewing query resolutions in DataLabs EDC database to ensure responses are satisfactory.
• Responsible for maintaining data management study files, including the Data Management Plan.
• Track delinquent requests for data clarification.
• Track delinquent electronic Case Report Form completion.
• Conducts Serious Adverse Event SAE , Laboratory Data and Tumor Evaluation reconciliation.
• Provide direct input to, and approval of vendor specifications including EDC, IVRS, lab and imaging vendors .
• Ensure that all data components are conducted in compliance with ICH, GCP, relevant SOPs, and global regulatory requirements.
• Responsible for overseeing all aspects of data cleaning for database lock at conclusion of clinical trials.

Confidential

Production Lead

• Act as the lead data management contact for Retail Information System RIS project for largest client in grocery data factory Procter Gamble from its inception.
• Manage a team of 3-4 data analysts.
• Use project management skills to effectively complete detailed project plans by identifying key tasks, deliverables, assignments, controls, and contingency plans.
• Provide service-oriented project support for all phases of the project.
• Effectively manage and/or provide technical leadership on complex tasks, including design of ad hoc SQL reports based on client requests with very tight timelines.
• Design and implement system processes and procedures to fulfill client needs/requests, including data analysis and data mining.
• Design, enforce, and maintain data integrity checks.
• Provide clear, timely communication across diverse groups with varying levels of technical knowledge.

Confidential

Clinical Data Manager

• Act as the lead data management contact on electronic patient-reported outcomes ePRO aspect of multiple clinical trials.
• Responsible for coordinating data management project workflow, including clinical data handling procedures, database cleaning and locking, and delivery of data to clients.
• Oversee query resolution process, including tracking of delinquent requests for data clarification.
• Develop customized user requirement specifications.
• Develop and maintain study-specific documentation, including the data management and quality plan.
• Develop, test, validate and maintain clinical databases.
• Perform edit specification creation, review, and testing.
• Perform database user acceptance testing.
• Develop and maintain report specifications.
• Write ad hoc queries based on data validation specifications.
• Use project management skills to effectively and efficiently track milestones and timelines for multiple clinical trials for multiple clients.

Confidential

• Set up database tables, reports, and data exports in SAS based on client-defined requirements.
• Create and maintain internal database requirements specification.
• Create, test, and maintain SAS code to transform data from proprietary eRT EXPeRT database to meet standard client specifications for weekly/bi-weekly/monthly data transfers and for regular weekly upload to the centralized eResearch Community database.
• Create customized database edit checks in collaboration with study lead data managers.
• Act as primary data management contact for cardiac safety aspect of multiple clinical trials.
• Maintain effective relationships with data management counterparts at multiple sponsors/CROs.
• Ensure clean and timely delivery of data to sponsors and CROs.
• Set up and maintain multiple protocol databases.
• Create and maintain study-specific documentation, including the data management plan, data transfer specification, and edit check specification.
• Define and execute internal database edit checks in SAS.
• Reconcile internal cardiac data with sponsor CRF data on a regular basis.
• Oversee query resolution process, including tracking of delinquent requests for data clarification, at both site and sponsor levels.
• Develop, test, validate, maintain, and lock clinical cardiac safety databases.
• Perform database user acceptance testing.
• Develop and maintain report specifications.
• Write ad hoc queries based on data validation specifications.
• Use project management skills to effectively and efficiently track milestones and timelines for multiple clinical trials for multiple clients.
• Ensure protocol compliance according to SOPs for support of all outgoing samples for diagnostic procedures.
• Ensure adherence to turnaround time requirements for all diagnostic procedures.