| Title: Business Analyst / Clinical Specialist
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| Location: Thousand Oaks, CA
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| Job Type: Contract
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| Compensation: per Hour
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| Reference Code: 946001-WQG
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| Description: The position will work with a cross functional team of Clinical, Biostatistical and Supply Chain representatives to support the design, implementation, and maintenance of outsourced electronic solutions to support a Clinical trial. The individual within this role will provide technical oversight to ensure that the study specific electronic solution adheres to the study protocol, industry regulations / best practices as well as company policies, procedures, and guidelines. This person will lead study-level system requirements meetings with internal and external clients; design and oversee the development of study specific technical documents; document possible risk; implement mitigation plans; and manage project related timelines and associated activities. This person will identify and track study-related technical issues to resolution and provide a supportive framework for continuous process and quality improvements.
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| Requirements: A Bachelor's degree in Life Science, Computer Science, Engineering, Business, or related discipline is required. 4 or more years of experience in clinical operations, clinical development or clinical quality assurance are required. Experience implementing clinical systems such as CTMS, EDC, IVRS, ePRO, or other related technology in the pharmaceutical / biotechnology industry is preferred. Candidates must be knowledgeable in Good clinical Practices and FDA regulations. Candidates should demonstrate project management and technical expertise, attention to detail, and excellent documentation and communication skills. Excellent time management and organization skills are required. Candidates must have sound problem resolution, judgment, and decision-making abilities. Candidates must be able to work well in a team-based environment with minimal supervision.
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