** Sr. Clinical Database Manager- I3 Statprobe- Ann Arbor, MI, Lexington, KY, Westerville, OH, Or In
UnitedHealth Group is an innovative leader in the health and well-being industry, serving more than 55 million Americans.
Through our family of companies, we contribute outstanding clinical insight with consumer-friendly services and advanced technology to help people achieve optimal health.
i3 Statprobe provides a full range of data management and biostatistical services for the pharmaceutical and biotechnology industries.
We not only pay relentless attention to the details, we also provide a higher level of thinking for data management and biostatistics.
As a UnitedHealth Group company, i3 Statprobe is part of a worldwide health care service organization that uses innovation, integrity and commitment to prepare for the future - and you can prepare for yours with us. It's a rare combination for success that only a career with i3 Statprobe can provide.
i3 Statprobe is seeking experienced Senior Clinical Database Managers for work in our Cary, NC; Ann Arbor, MI; or Lexington, KY offices.
Major Responsibilities: Coordinates the development of data management systems solutions for use in worldwide clinical trials Manages tight deadlines for designing, developing, and coding systems solutions within the designated data management tool(s) Participates in Study Development Process (SDP/eSDP/CSIM) meetings as indicated Designs and develops data management systems solutions using the standard reference library Develops and supports an atmosphere of teamwork among the Study Set-up staff and within the Medical organization as a whole Liaisons with study team members to determine and confirm study set-up specifications Reviews selected panels and rules for design and usability to prevent storage, reporting or standards issues Works with and coordinates the efforts of contract help in order to develop data management system solutions Proactively provides guidance at meetings regarding study set-up processes and timelines Communicates with management and/or study team regarding resourcing needs Coordinates, documents, and communicates changes in study set-up processes across medical worldwide Coaches and counsels new Medical and affiliate personnel regarding the DMA- Study Set-up role in the SDP process Provides study set-up expertise on cross-functional committees Coordinates with the Data Collection Coordinator (DCC), Clinical Data Management Coordinator (CDMC), and others on the migration and validation of eCRFs Ensures compliance with data standards as appropriate Maintains DMA- Study Set-up metrics to support business planning processes Reformats and updates forms, panels, and rules as needed Coordinates and maintains the study set-up change control process Coordinates and maintains the study set-up approval process BA/BS degree in a related field Minimum of 5 years of clinical data programming or related experience Proficiency in ClinTrial and/or Inform database set-up, programming and administration Proficiency in PL/SQL, XML, Visual Basic, and/or VB Script Self-motivated, willing to learn and demonstrates success at current job Excellent people and communication skills (written and oral) Knowledge of CSQ validation processes Knowledge of the clinical trial process is preferred Extensive experience and understanding of lab and other 3rd party data Possesses a positive attitude and works well with others Knowledgeable in all areas of database setup and programming for clinical studies Demonstrated programming and logic skills Diversity creates a healthier atmosphere: an equal opportunity employer, M/F/D/V.
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