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A - Oracle Clinical Data Manager

Company: Monroe Staffing Services

Location: Paramus, NJ

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Name: Rich Cosmedy
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Job Description

Applicant will work within Database Administration with Ad Hoc SAS Programmers, Integrated Review Administrator, OC DBA/Database Manager and CRF designer to meet the needs of various customers. Customers include Clinical, Programming, Data Management and medical. Applicant will be responsible for Ad Hoc SQL Programming, OC procedure programming and OC study Database Build and Maintenance.  Responsibilities for this position include Programming in PL/SQL and or SQL for ad hoc reports (E.g. metric reports from the backend OC tables). Working with the Integrated Review administrator to deploy Ad Hoc SQL reports/SQL code to users via integrated review. Building and designing clinical studies in Oracle Clinical (OC) in concert with Data Managers. Responsible for the documentation, development and maintenance of the OC Global Library according to agreed upon standards. Providing assistance to Data Managers in ensuring that CRFs are compatibly designed with OC standards. Interaction with the SAS. Programming department in standardization of SAS Data Structures. Specific responsibilities: OC study planning, design and standardization. Maintenance of OC and TMS administrative reference code lists. Creation and documentation of DCMs, DCIs and workbooks for clinical studies. Creation and programming of OC validation and derivation procedures including documentation and testing plan. Global Library maintenance (Questions, Question groups, DCMs and DVGs). Interacting with external vendors concerning external data into OC.

 

External data loads, and trouble shooting data loads. OC lab setup including reference ranges, panic flags, unit conversions and Normlab2. Maintenance and upkeep of study view descriptions and study view templates including extended attributes.

Building ad hoc reports in integrated review; Training and mentoring in IR to be provided Applicant will be expected to contribute in refining current Database Administration process as well as revamping and develop old/new processes to increase efficiency. Minimum qulaificaltions including prior experience and knowledge required in order to perform this job include Five or more years experience in Oracle Clinical, with at least two years spent in a database programming capacity. In depth experience with Oracle Clinical database design, PL/SQL.


Job Requirements

Minimum training/education: Degree in life sciences, MIS, pharmacy or nursing; advanced degree desirable. Formal or on the job training in clinical trial methodology and Good Clinical Practice (GCP). Ability to listen and understand the customer's needs

Additional Desirable Qualifications necessary to successfully perform this

position: Oracle Clinical/TMS validation experience. Familiarity and working knowledge of Oracle Clinical/TMS underlying database tables. Knowledge and experience in Oracle Clinical add-ons such as Integrated Review and or Oracle Discover and query tools. Good interpersonal skills. Exhibits professionalism and communicated effectively. Capable of handling multiple projects and demonstrates ability to set priorities. Flexible and dependable. Reporting relationship for this position: The Oracle Clinical Programmer/ Database Manager reports to the Manager of Database Administration

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