Discussion:
(908) US-NJ-Northern NJ: Clinical Data Manager (29793)
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ISHunter.com
2004-06-09 16:07:12 UTC
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Title ...... Clinical Data Manager
Skills ..... clinical trials, Data management, oracle and SAS
Location ... Northern NJ, NJ
Area Code .. 908
Term ....... Contract
Length ..... Long-Term/FT
Pay ........ Competitive

Description
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A minimum of 3-5 years experience managing clinical pharmaceutical data in the support of NDA submissions
or in the support of product marketing activities.
Must be experienced in the extraction and manipulation of data in an Oracle environment and have demonstrated knowledge of SQL or other database query language.
Knowledge of programming in SAS and Visual Basic for
Excel will be useful and is considered a plus. Must
have a strong data management background, including
experience in different methods of data entry, cleaning and review, report generation and validation.
Must possess strong communication and analytical skills. An ability to work in a diverse international team environment is essential. Applicant must possess strong computer skills in a Windows 95/98 environment and be an experienced user of Microsoft Word, Excel and Powerpoint. Knowledge of database development for web-based applications is desirable.

At least one year's experience in a management role is preferred.

Education Level Preferred: Bachelor s degree in a science related field. A Master s degree, or higher is preferred.

Job Description:

1.Conduct and/or guide all data management activities of the group, including receipt, review, entry and
validation of appropriate forms into the Registry.
2.Develop and maintain a Data Quality Management Plan
for Corporate Clinical Trials Registry. Write, execute and review edit checks for the daily cleaning and validation of Registry data. Work with study
managers on World Wide Teams and in Country Medical Offices to resolve data discrepancies.
3.Participate in the development of validated reports
using SDLC process. Participation could include development of user requirements, software
development and/or user testing.
4.Create and generate standard reports from the
Registry using Oracle query tools (e.g. SQL, Brio Query, Microsoft Query etc.) and SAS. Process ad-hoc
or special requests for information and reports from the Registry.
5.Provide clinical data management expertise based upon clinical development understanding and
experience. Ensure that corporate and departmental Standard Operating Procedures are adhered to for data
management functions. Lead and/or contribute to special projects to build best practices and quality principles into the management of all Registry related activities.
6.Provide periodic updates to upper management on the
performance and efficiency of the Registry and of system users. Interact with the Registry development
team in identifying and describing improvements and features that could be added to future releases of the Registry front-end interfaces (CTM, CCID, RighTrack).



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GISuser
2004-06-09 19:19:27 UTC
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Glenn

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