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Clinical Data Manager

Company: Global Channel Management, Inc.
Location: Staten Island
Posted on: May 17, 2018

Job Description:

Clinical Data Manager needs 5 years of Clinical Data Management experience Clinical Data Manager requires: degree in computer science/technical/scientific field Training in GCP, GMP and pertinent sections of FDA Code of Federal Regulations (e.g. CFR 21 part 11) SAS clinical trial protocols, analysis plans, analysis requirements documents, company and departmental SOPs PageMaker or InDesign Medidata Trial Master File (TMF) and Site Regulatory file Project management diagnostics industry Clinical Data Manager duties: Coordinate and ensure the timely completion of all Data Management activities for assigned projects following appropriate regulatory guidelines, and company and department SOPs. Provide technical and Data Management expertise as a member of a cross-functional project team. Write clinical Data Management Plans and associated documents (i.e., database specifications, data entry guidelines) and drive the project team review and approval process. Facilitate clinical trial eCRF development or other data capture processes. Oversee and/or conduct and document the User Acceptance Testing of data entry screens, database build and edit check programming. Process and manage instrument generated data including edit checks using SAS.

Keywords: Global Channel Management, Inc., New York, Clinical Data Manager, Healthcare, Staten Island, New York

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