Clinical Data Manager needed for PERM position at pharma co. in

Kelly Clinical Resources is seeking a Clinical Data Manager for a pharmaceutical company in Costa Mesa, CA.

This is a permanent position.

Overview:
This position represents the first project management level within Clinical Data Management Group. Clinical Data Management has diverse areas of responsibility. The assignment of staff in Data Management can either be project specific or provide general support of data management needs in R&D. The diversity of support provided by Clinical Data Management may require flexible assignments.
Responsibilities:
' Create and maintain Oracle Clinical database from clinical research efforts sponsored by company ' this can constitute individual study or to a project.
' Interact with CROs contracted by Company (Primarily Clinical Research) and Company Clinical Research Associates (CRA's) to ensure the quality and reliability of CRO-created databases.
' Create, update and maintain Standard Company CRF Terminology Dictionary.
' Derive, modify and maintain project/protocol specific dictionaries extracted from the standard clinical dictionaries, such as MedDRA and WHOART dictionaries.
' Case Report Forms (CRFs) processing related tasks:
 Design CRFs according to study protocol.
 Develop edit specifications and data conventions.
 Develop data entry specifications according to Oracle Clinical requirements.
 Create and maintain Oracle Clinical database.
 Harmonize data received from external sources (mainly CROs) with Company standards.
 Create SAS data sets from Oracle Clinical database.
 Establish workflow and interaction protocol between Data Management and CRO(s) contracted for Company clinical studies.
 Training of new staff members in Data Management
 Tutor or brief Clinical Research staff on Data Management responsibilities and interactions between Data Management and Clinical Research.
 Supervision of junior or temporary Data Management staff.
 Other tasks that may be assigned by management at certain times.
Qualifications:
' College degree required.
' Solid knowledge of clinical research and clinical data management process as practiced by the pharmaceutical industry.
' Solid knowledge of Oracle Clinical software; or, alternatively, solid knowledge of a pharmaceutical industry standard clinical data processing software.
' Superior communicational and inter-personal skills and a team player.
' Occasional requirement of working long hours.
' Work effectively under tight time constraints.
' Occasional domestic or international travel




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