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Clinical Data Manager II (temp)

Arena Pharmaceuticals, Inc.

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Location: San Diego, CA Posted Date: 4/9/2013 Position Type: Contract, Full time Job Code: 0343100313 Required Education: Bachelors Degree Areas of Expertise Desired: Clinical Data Management

Description

Arena Pharmaceuticals, Inc., a leading San Diego based biotechnology company, is seeking a candidate for the CLINICAL DATA MANAGER II position.  Email responses to: jobs@arenapharm.com  or apply online at http://www.arenapharm.com/careers.aspx Please reference Job code: 0343100313.

Description:
Under general supervision, the Clinical Data Manager II will be part of the Data Management team responsible for study specific data management activities, including study set-up, maintenance, data review and clarification.

Essential Duties and Responsibilities:
• Review protocols and provide input relevant to data management issues;
• Oversee all data management activities within CROs and database build/maintenance within EDC vendor;
• Manage external lab vendors, transfer specifications, and transfer timelines;
• Review/create study specific data management documentation (i.e. Data Management Plans, Database Specifications, Edit Check Specifications, clinical data query handling and resolution, Vendor data Reconciliation Plans, SAE Reconciliation Plans, etc.);
• Perform User Acceptance Testing of EDC system;
• Perform/oversee clinical study data maintenance, data listings, enter queries, review query resolutions, etc.;
• Perform Validation of SAS programming within Data Management;
• Provide input on general data management documents such as SOPs, standards, templates, etc.

Requirements

Education: Bachelor’s Degree in Life Sciences or Mathematics and/or four to six years of experience in clinical data management on-the-job training in clinical trial methodology and Good Clinical Practice

Experience and Specific Skills:  Must have a basic to moderate understanding of all aspects involved in the data management responsibilities throughout a clinical trial; appropriate experience with an understanding of at least one clinical data management system (e.g., Medidata Rave, Inform, Clintrial); good organizational and documentation skills; a general understanding of regulatory guidance and regulations (e.g., ICH, 21CFRpart11, etc.); and be a team player who works effectively with other disciplines.

Supervisory Responsibilities: None

Physical Demands/Work Environment:  This position is office-based; sitting and computer use up to eight hours per day.
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