ob Description
The objective of a Clinical Data
Manager I is to act as the lead data manager for one or more projects
or to provide support to the lead data manager. CDM I's will lead all
data management activities for individual, limited volume/complexity
studies with mentoring from a manager as required. CDM I's work
independently and efficiently perform, with quality, all data management
activities within an assigned study. CDM I's may mentor junior level
staff on all associated tasks within a study. CDM I's liaise with the
sponsor as required and communicate with management regarding all data
management activities within their studies. Responsibilities include:
Ensures database accuracy according to departmental operating procedures
Performs a QC review of the data and makes corrections to the DM database
Develops data validation manual
Defines and tests databases and data validation system
Represents Data Management in all cross functional meetings relating to the study
Reviews data listings for consistency and accuracy of data
Develops and maintains data management project documentation files
Performs independent reviews of data management deliverables following documented guidelines
Acts as an interdepartmental and sponsor liaison for all DM study activities
Produces project-specific status reports for management and sponsors
Monitors study metrics
Analyzes and resolves discrepancies in data validation or other reports
Education and Experience:
Bachelor's degree OR certification in a related allied health profession from an appropriately accredited institution (i.e. RN, MT, PA, RPh, RT)
Minimum 3 years work experience in a professional environment, preferably within a clinical or medical data environment, including 2 years of data management experience
Or a combination of performance, education and prior directly related experience may be considered as equivalent to the above requirements provided that the individual possesses the following knowledge, skills, and abilities to perform the job requirements satisfactorily
Education:UG -Any Graduate - Any Specialization, Graduation Not Required
PG - Any Postgraduate - Any Specialization, Post Graduation Not Required
Doctorate - Any Doctorate - Any Specialization, Doctorate Not Required
Ensures database accuracy according to departmental operating procedures
Performs a QC review of the data and makes corrections to the DM database
Develops data validation manual
Defines and tests databases and data validation system
Represents Data Management in all cross functional meetings relating to the study
Reviews data listings for consistency and accuracy of data
Develops and maintains data management project documentation files
Performs independent reviews of data management deliverables following documented guidelines
Acts as an interdepartmental and sponsor liaison for all DM study activities
Produces project-specific status reports for management and sponsors
Monitors study metrics
Analyzes and resolves discrepancies in data validation or other reports
Education and Experience:
Bachelor's degree OR certification in a related allied health profession from an appropriately accredited institution (i.e. RN, MT, PA, RPh, RT)
Minimum 3 years work experience in a professional environment, preferably within a clinical or medical data environment, including 2 years of data management experience
Or a combination of performance, education and prior directly related experience may be considered as equivalent to the above requirements provided that the individual possesses the following knowledge, skills, and abilities to perform the job requirements satisfactorily
Desired Profile
Education:UG -Any Graduate - Any Specialization, Graduation Not Required
PG - Any Postgraduate - Any Specialization, Post Graduation Not Required
Doctorate - Any Doctorate - Any Specialization, Doctorate Not Required
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