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Data Manager Resume Profile

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.

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