Essential Skills Needed for Assignment:
• Oversee all aspects of data management tasks performed by external vendor: Review CRF, database creation and dataset structure, Data Management Plan, Data Quality Plan, Data Review Guidelines and edit specifications;
• Request and review specific project status tracking reports;
• Review data and queries as appropriate using Electronic Data Capture (EDC);
• Perform internal activities associated with database lock (e.g. TLF review, SAE reconciliation, coding reconciliation, document collection);
• Interface with in-house staff: Participate on Project Teams; Review protocols, statistical analysis plans, monitoring guidelines and Clinical Study Reports;
• Work closely with Medical Monitor(s) to review CRF coding for logic, consistency and medical appropriateness.
• Vendor Management: Over site of external vendors to assure that all clinical data is properly collected, cleaned and formatted, to allow for proper analysis and interpretation required for inclusion into reports and regulatory submissions.
• Assist Head of Data Management in identification, creation and maintenance of department procedures: Participate in departmental initiatives related to process building/improvement and integration of new technology.
• Assist in Regulatory Submissions/Audits
• Coordinate and liaise globally within the organization, as necessary, regarding global Data Management procedures, processes and standards.
• Design, develop, and document programs (SAS, including knowledge of BASE/SAS, SAS Macros, ODS, and SAS/Graph or other computer programming and data analysis languages) to process clinical data and perform statistical analysis.
Education and Experience:
• Bachelor's Degree Required with 8+ Years of Related Experience Oncology experience preferred
• Very Good Written and Oral Communication Skills
• Excellent Mathematical Skills and Problem Solving Skills
• Strong Experience with Electronic Data Capture Systems
• SAS Drug Development experience or knowledge preferred (Version 4.3 or higher)
• Team player, flexibility
• Self starter, strong attention to detail
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