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Clinical Data Analyst II

Job Description Summary
Job Description
The Clinical Data Analyst II is responsible for the design, development, implementation and maintenance for clinical databases for the capture of both Clinical data as well as Trial Management data. The Clinical Data Analyst II will be the primary architect of the database(s) for the projects for which they are assigned, working closely with the Clinical Data Manager and/or Clinical Associate for the project. In addition to database design and development, the Clinical Data Analyst II is responsible for assuring the integrity of data collected in the database. This includes developing and maintaining electronic data capture tools and tables, programs for error identification, output generation, testing and generating requisite documentation. Provides necessary training and support to clinical associates. Provides mentoring and technical support to Clinical Data Analysts.
Responsibilities:
Plans, coordinates, designs, implements, performs and documents database design, development and implementation for assigned clinical trials projects. Ensures that data security and data integrity is maintained.
Develops all aspects Clinical Data Management work products including database tables, code lists, data capture screens and tools, edit check programs, reports, listings and output. May support paper based, electronic data capture (EDC), or hybrid studies.
Develops, documents and implements validation test plans for various database and data collection components.
Exhibits a greater understanding of CRF, database and edit check design and mentors junior staff members.
Creates reports to facilitate study team review and validation of the data.
Assists statisticians and other programmers in understanding the database when they are generating specialized reports from the database. Assist in testing the validity of the data on the specialized reports.
Exhibits a greater understanding of outputs and mentors junior staff members.
Maintains appropriate documentation including, but not limited to, Data Management Plans, CRF and Edit Specifications, Data Dictionaries, Edit Check Definitions, and Analysis Output Definitions.
Makes recommendations for future expansion of the system to include the implementation of new systems and technologies that improve performance, availability, service and management of the database(s).
Qualifications:
Bachelor's degree in Computer Science, Information Technology, Life Sciences required.
Minimum of 5 years of relevant data analyst experience is required. Preferred experience areas include the life sciences or other relevant technical area, such as clinical trials, Regulatory Affairs, or Quality.
Experience working in a regulated environment, preferably Medical Device or CRO with Device and IVD focus required.
Experience and expertise with Clinical Data Management systems and relational database management systems including SQL is required.
Scientific background and/or experience with Clinical Trials or FDA Submissions is preferred.
Strong Knowledge of GCDMP, GCP, ICH guidelines. Adheres to policies and procedures as appropriate to comply with ISO 9000, GCP and with the FDA Guidance for Industry for Computerized Systems used in Clinical Trials. Knowledge of CDISC/CDASH is a plus.
Familiarity or knowledge of SAS, JReview, Business Objects or other reporting tools is a plus.
Experience with electronic data capture and trial management is a plus.
Primary Work LocationUSA MD - Baltimore
Additional LocationsUSA NJ - Franklin Lakes
Work Shift



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