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| Job Title: |
Clinical Database Set- Up Manager- i3 Statprobe |
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Job Category:
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IT/IS |
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Job description:
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We currently have needs for several experienced Clinical Database Set-Up Manager
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.
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Skills:
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B.A./B.S. 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.
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Employment type:
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Salary Range:
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Unspecified |
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| Other Information |
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Degree:
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Bachelors |
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Experience (year):
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5 |
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Job Location:
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Austin - TX - USA |
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Post Date:
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11/17/2008 |
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