• Charleston, SC, USA
  • Full Time

Data Manager III

The Data Manager III / Senior Data Manager (DMIII/SDM) contributes to and coordinates efforts relating to maximum utilization of an enterprise wide data structure as well as individual projects requiring data analysis. The DMIII/SDM contributes to and aids in developing data standards and best practices for data capture applications. The DMIII/SDM contributes to planning, designing, and implementing the clinical database, data review processes, data integration processes, data export processes, database archiving and subject data distribution to the clinical sites

Primary Responsibilities

  • Assists in determining value targets/metrics with the Sponsor and CRO team and to convey the same to the clinical site teams regarding data submission, EDC entry, source document upload, query resolution and datalock. Activities may include interaction with development, clinical and end-user personnel to confirm data elements per protocol requirements are being captured in CRF/eCRF design.
  • DMIII/SDM may contribute to and will adhere to data flow processes/algorithms, query processes and resolution, CRF completion guidelines alerting clinical and data management of intervention needs based upon pre-determined quality thresholds.
  • Works under general supervision, assists in data review, query and data cleaning activities associated with maintenance and ultimately transfer of the database.
  • Contributes to the elements the DM Programmer will include in building dashboards within eTechnology platforms (EDC, IWRS, IP inventory).
  • Responsibly confers with medical and clinical staff for clarification of therapeutic nuances.
  • Reports to the Data Management Project Manager (DM_PM), and provides progress and metric reports to the study team and sponsor. DMIII/SDM serves as a liaison between internal and external stakeholders.
  • Trains end users generally on applications or study specific guidance.
  • The analyst will take directions from the clinical and sponsors stakeholders to translate clinical needs into actionable information and provide technical ways in populating and automating operational and quality reports.
  • The DMIII/SDM may use SAS or Excel to provide advanced analytical tools, recall alerts and ensure data quality, data integrity, and aggregate information and provide predictive analytics from various large databases.
  • DMIII/SDM helps drive Data Management and enterprise wide goals.

Knowledge, Skills and Abilities

  • Extract data from multiple data sources and use programming techniques to merge data to create meaningful interim reports for critical path objectives
  • Investigate and evaluate alternative solutions to meet business needs documents methods, specifications and findings clearly; write/present results, findings and conclusions
  • Create/evaluate data needs of assigned projects and assures the integrity of data
  • Project and resource management
  • Participate in the development of project plans and timelines
  • Manage projects and customer expectations to achieve satisfaction
  • Responsible for commitments to quality and on-time deliverables
  • Maintain total confidence, all files, documents and records that pertain to the operation of business of Cap Management Systems
  • All other job-related duties as it relates to the job function or as delegated by the management team
  • Advanced computer skills
  • Generate, resolve and track queries to address problematic data identified during data review activities and apply proper modification/correction to the database.
  • Development of Data Management and Quality Control Plans that will deliver accurate, timely, consistent, and quality clinical data
  • Define edit checks to be programmed for the study/project and review of programmed edit checks.
  • Review filing systems/eTMF in routine for key study documentation.
  • Code Case Report Form (CRF) verbatim terms using standard or client supplied dictionaries to standardize nomenclature.
  • Perform reconciliation of the clinical and safety databases.
  • Track study progress and issue periodic status reports.
  • Ensure the completion of all quality control measures necessary for the finalization and transfer of the database and related materials to the client.
  • Strong mathematical and statistical skills with strong emphasis on analysis of large databases
  • Excellent proficiency in Microsoft Office Suite (Word, Excel, Access and Power Point and Visio)
  • Strong problem solving and critical thinking skills with demonstrated ability to focus on details
  • Ability to learn quickly and work on multiple projects simultaneously, and demonstrated ability to work in a fast-paced, demanding, and stimulating environment
  • Must be a team player and able to work independently as well as take direction from the supervisor, with strong collaboration and communication skills within and across teams
  • Advanced programming techniques, relational databases, data systems and data warehouses
  • Effective presentation skills
  • Assemble datasets to enable statistical services to perform analyses on complex and varied healthcare data to evaluate clinical performance, outcomes, and population's health
  • Manage all functions & activities related to Data Entry, like First Pass and Second Pass Data Entry (if applicable in the event paper-based system used), Review of Data Entry, and Database update.
  • DMIII/SDM must be competent to work independently in most phases of database management and clinical data review and possess knowledge to gather the data to assess performance trending to prevent breach of quality thresholds.

Education and Experience

  • Bachelor or Master's Degree in Biostatistics, Statistics, Mathematics, Epidemiology, Public Health or related field or equivalent work experience
  • 4+ years' experience in analytics
  • Hands on experience with Electronic Data Capture systems specifically Medidata Rave and/or IBM EDC
  • Experience with Data Management practices and relational database management software systems
  • Proven strength in problem solving and root cause analysis
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