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Miles
Km80.5

Clinical Data Manager ll (Contract)

Exelixis, Inc.

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Location: South San Francisco, CA Posted Date: 4/17/2013 Position Type: Contract Job Code: 1190 Required Education: Bachelors Degree Areas of Expertise Desired: Clinical Data Management
Quality Assurance
Technical Services

Description

SUMMARY:
Responsible for the design, documentation, implementation and execution of data collection and data quality review in clinical research studies.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Provide expertise in data management to support clinical studies performed or managed by Exelixis.
• Provide clear verbal or written information and hands-on support to project team members and to CROs related to CRF design, database design, data management plans, edit checks/quality review plans and query resolution processes.
• Manage data transfers with CROs, SAE/AE reconciliation and thesaurus coding processes.
• Manage the locking, transfer, and archiving of study databases.
• Perform Exelixis internal clinical data review to supplement the data review done by the CRO.

Requirements

EDUCATION/EXPERIENCE/SKILLS:

Education and Experience:
• BS/BA degree in related discipline and 4 years of related experience; or,
• MS/MA/PhD/RN degree in related discipline and 3 years of related experience; or,
• Equivalent combination of education and experience.

Experience:
• Typically requires a minimum of 4 years of related experience and/or combination of experience and education/training.
• A minimum of 3 years of clinical data management experience is also required in the bio/pharmaceutical industry or clinical trials.

Knowledge/Skills/Abilities:
• Knowledge of GCP is essential.
• Experience with electronic Clinical Database Systems is required and experience with electronic reporting applications preferred.
• Experience with electronic data capture (EDC) is preferred.
• Experience with oncology clinical trials is preferred.

JOB COMPLEXITY:
• Frequent use and application of technical standards, principles, theories, concepts and techniques.
• Provide solutions to a variety of technical problems of moderate scope and complexity.
• Works under general supervision.
• Follows established procedures.
• Work is reviewed for soundness of technical judgment, overall adequacy and accuracy.
• Contributes to the completion of milestones associated with specific projects. Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules and may result in the allocation of additional resources.
• Regular inter-organizational and outside contacts on routine matters.



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