The Clinical Science Analyst position at Cook Research Incorporated is responsible for providing scientific support, analysis and expertise. The Clinical Science Analyst coordinates with cross-functional teams in processing, analyzing and summarizing results and data.
• Lead efforts for the analysis, and reporting of clinical and imaging data to relevant clinical stakeholders
• In collaboration with Clinical Scientist, coordinate the presentation of information to DSMB, in accordance with the DSMB Charter
• Collaborate with Clinical Scientist, Clinical Project Manager and Statistician in review and summary of clinical study data
• Provide support and review annual reports in collaboration with Clinical Project Manager
• Provide support in the analysis and summary of data for publications, presentations and regulatory submissions
• Provide support and assist in reviewing materials for Investigator Meetings and Site Initiation Meetings, as needed
• Review and provide input to clinical study-related documents, plans and training materials (e.g., CIP, CRF Specifications, Clinical Study Overview Presentation, Progress Report), as needed
• In studies with an imaging component, coordinate plan for receipt and review of imaging
• Maintain effective communication with cross functional teams and stakeholders
• Masters degree in Life Sciences or Engineering preferred
• Strong analytic skills
• Strong verbal and written communication skills
• Extensive experience in the conduct and management of clinical studies
• Proven ability to exercise sound judgement in independent decision making
• Working knowledge of the regulatory authorities and other regulatory requirements that may impact global clinical studies
• Conscientious, influential person with an outstanding work ethic and strong personal discipline
• Willingness and capability to handle multiple projects and responsibilities
• Excellent organization, leadership and problem-solving skills
• Excellent written and verbal communication skills
• Sufficiently assertive to deal with confrontational situations while recognizing the need to communicate in an effective and diplomatic manner
• Excellent relational skills and desire to mentor others
• Ability to present a professional and personable demeanor in all interactions
• Experience in writing technical documents
• Willingness and ability to travel sporadically, as needed
• Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position
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