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.
- 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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