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Clinical Data Manager

PRINCIPLE DUTIES AND RESPONSIBILITIES:

  • Generates routine and ad-hoc reports using internal and external data sources to complete data requests
  •  Leads and performs clinical data management tasks for assigned studies in accordance with Syntactx SOP’s and policies and practices
  • Provides data outputs for analysis
  • Prepares and distributes project status reports to project team and management.
  • Designs and modifies CRFs
  • Creates and maintains project documentation, including, but not limited to, Data Management Manual, CRF Completion Guidelines and validation specifications, and work instructions for assigned projects
  • Responsible for the initiation and approval of the building, testing and validation of clinical databases, subsequent changes in clinical databases and data validation activities
  • Works with study team and coordinates all data management functions
  • Adheres to procedures surrounding retention of data, records, and information for clinical studies
  • Assists in the development and maintenance of the data architecture to provide a foundation for database design
  • Integrates data from internal or external sources to provide data for analysis and/or reporting
  • Presents information in a concise, user-friendly format by determining target audience needs to support decision processes outcomes
  • Performs related duties as required and assigned.

QUALIFICATIONS:

  • Baccalaureate degree in a math or science field
  • Proficiency in all Office applications and Excel in particular
  • At least 2-3 years of clinical data management experience related to pharmaceutical or medical device trials
  • Experience in the creation of a Data Management Plan
  • Experience in the development of electronic case report forms
  • Knowledge of validation and user acceptance testing for electronic data capture systems
  • Must be able to work independently following a period of specific training
  • Must possess excellent verbal and written communication skills
  • Must have strong organizational skills and be attentive to detail
  • Demonstrate a high degree of personal and professional integrity

This is a Monday through Friday in office postion at our downtown Manhattan office. 

 

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