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Clinical Data Manager

Company: Beacon Hill Staffing Group - Pharma
Location: Newark
Posted on: January 15, 2020

Job Description:

The primary objective of this position is to ensure clinical study data is collected, handled and validated in an appropriate and consistent manner to ensure a high quality database is delivered for statistical analysis within agreed upon project timelines. Evaluate new technologies, development of Case Report Forms (CRFs), development of database specifications, development of edit check specifications and the Data Management Plan, conduct data review, query generation/resolution, data coding, electronic data reconciliation and identification of protocol deviations. Essential Job Functions: Provide input into study protocols to ensure the data collection requirements are clear and supportive of the study endpoints. Design high quality CRFs in consultation with a cross functional team that accurately reflect the data collection requirements identified in the study protocol and that are consistent with internal standards. Assist with database design to ensure it meets requirements for the entry and reporting of clinical data. Develop CRF Completion Instructions to serve as an aid for site personnel to complete the CRFs. Define Edit Check specifications and work with Database Programmers to ensure accurate and timely programming. Develop Data Management Plan. Perform User Acceptance Testing to ensure the quality and integrity of the clinical study database design and associated edit check programming prior to the study database being released to collect data. Conduct data review and associated query generation/resolution. Perform Database Finalization activities and deliver quality results within agreed upon project timelines. Perform data reconciliation activities by comparing CRF data to Non-CRF data from external vendors. Maintains accurate and complete study records. Basic Qualifications: Minimum 5 years Clinical Data management experience. Minimum 3 years Oracle Clinical required. Advanced knowledge of database application concepts. Advanced knowledge of data management processes and industry standards. Minimum 5 years EDC/RDC technology experience required. Fundamental knowledge of adverse event and medication coding dictionaries preferred Experience with MS Word, Excel and Powerpoint.

Keywords: Beacon Hill Staffing Group - Pharma, Newark , Clinical Data Manager, Healthcare , Newark, New Jersey

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