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Clinical Data Administrator - Arvada, CO

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Note: This employment opportunity has expired and is no longer available. It has been retained for historical interest only.
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COMPANY: Sorin Group USA, Inc.

POSITION: Clinical Data Administrator

LOCATION: Arvada, CO

DESCRIPTION: The Clinical Data Administrator provides services and support activities for the conduct of clinical research. Performs the following data related activities: Designs, develops, evaluates and modifies computer programs to analyze and evaluate clinical data. Writes programs and develops systems related to the collection and retrieval of data from clinical studies. The Clinical Data Administrator also develops processes and reviews clinical trial data to ensure accuracy and consistency, CRF tracking, data review, data QA validation, database updates, adverse event and query reconciliation, safety coding, database queries and data extraction. Conducts review, audit, and analysis of data entry and data verification, coordinates Medical Central File activities, and develops and reviews data QA reports. The Clinical Data Administrator may provide in-house review of case report forms and queries, and reports on study status. Works within the clinical research team to support the use of Clinical studies database and Clinical Trials Management software while satisfying applicable regulatory, protocol, and SOP requirements for clinical trials.


REQUIRED SKILLS:

  • Education: B.S. degree in computer science, information systems, health sciences field or equivalent discipline.
  • Experience: Two plus years of work experience as a programmer/analyst in clinical studies or other scientific environment. Proficiency with SAS software (SAS Base, SAS/AF, SQL, SAS Macro language and SAS/Graph) desired.
  • Knowledge, skills and abilities: experience in Oracle Clinical Database; experience in programming languages (e.g. SQL, Crystal reports); MS Office suite; writes clear and concise communications; working knowledge of medical terminology, specifically the cardiovascular system; ability to travel a minimum of 10%; personal attributes: independent, decisive, accurate, detail-oriented, multi-tasking, organized, and flexible.


RESPONSIBILITIES:

  • Clinical Programming
    • Develop user interface for generating reports from clinical data for use by study monitors, managers, and other clinical staff.
    • Develop, write and document programs to facilitate transfer of data from and to outside sources.
    • Develop programs to flag data discrepancies and create data exception reports for use by study monitors and site personnel.
    • Support the clinical statistician with preparation of programs to analyze clinical data.
    • Develop programs to provide graphical and tabular presentation of clinical data as required for regulatory submissions, publications, and other presentations.
  • Data integrity oversight
    • Conduct data QC activities including review of CRFs, edit checks, data listings and reports, data tables, and data queries to identify errors and inconsistencies.
    • Generate queries to investigative sites and review query responses from sites
    • Perform QC/QA of CRF tracking and query management system
    • Assist with review and coding of adverse event reports.
    • Report data QA findings and work with Clinical staff to develop corrective action for database corrections.
    • Generate and review computer listings and data summaries for clinical studies and for use by clinical research associates, investigators, and other requestors.
    • Participate in the definition, development, and validation of data QC reports.
    • Ensure data management activities comply with study timelines, internal SOPs and procedures, and all regulatory requirements
    • Ensure applicable regulatory and protocol guidelines of data reporting are satisfied for accuracy, completeness, and timelines
    • Responsible for managing the Medical Central File Room for North American studies: works with NA Clinical personnel to create, update and maintain study master files, site administration files, and patient files
    • Responsible for set up and maintenance of clinical studies in the Sorin Clinical Trials Management System.
    • Generate reports from the Clinical Study database and the Clinical Trials Management System: track status of study (e.g. enrollments, dropouts, compliance), data QA /QC.
    • Assist with development of clinical processes, SOPs and database conventions
    • Coordinate data management activities with Sorin Data Management staff in Italy
    • Assist with Case Report Form development
    • Manage randomization schedules if required
    • Perform other duties as assigned.


CONTACT INFORMATION: Web site: http://www.sorin-ushv.com/index.php?id=42&page=Career_Opportunities#form