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  • Clinical Data Manager Job Responsibilities:
    Develop project-specific data management plans that address areas such as data coding, reporting, or transfer, database locks, and work flow processes. Generate data queries based on validation checks or errors and omissions identified during data entry to resolve identified problems. Design and validate clinical databases including designing or testing logic checks. Design CRF forms for receiving, processing, or tracking data. Process clinical data including receipt, entry, verification, or filing of information. Perform quality control audits to ensure accuracy, completeness, or proper usage of clinical systems and data. Monitor work productivity or quality to ensure compliance with standard operating procedures (SOPs). Supervise the work of data management project staff. Confer with end users to define or implement clinical system requirements such as data release formats, delivery schedules, and testing protocols. Participate in Database testing-User Acceptance Testing (Medidata RAVE, Datalabs and Phase forward/Inform)  Conducted Functional, Integration, System, Regression, Performance, Load/Stress, White and Black Box Testing. Participated in developing Data Listings for Data Review and Data cleaning activities using SAS/Base. Provided support in applications such as Oracle Clinical, OC/RDC, INFORM and RAVE. Developed test scenarios and test procedures based on the Oracle Clinical Application. Use programming languages such as SAS, PL/SQL, SPSS, as well as client and server applications development processes.  Responsible for supporting data lock activities, including planning and executing listing reviews, database audit, identifying edit check maintenance needs, managing and resolving queries, identifying remaining clinical and monitoring tasks. Must have strong knowledge of INFORM, Medidata, SAS, Oracle Clinical, Documentum, Proc SQL, Oracle, PL/SQL, 21CFR Part 11, Query Management, MedDRA, MS Visio and MS Project. JOB LOCATION:  40 Eisenhower Drive, #201, Paramus, NJ 07652. SALARY: $97,552.00/yr. 40 hrs/week (9:00 AM to 5:00 PM). Send resumes to: HR, 40 Eisenhower Drive, Suite 201, Paramus NJ 07652
    Masters in Science or Biotechnology or a Bachelors in Bioinformatics plus 5 years of progressive experience in Clinical Research or Pharmaceuticals or Clinical Data Management .Any suitable combination of education, training or experience is acceptable.

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