Associate Director, Clinical Data Management

Associate Director, Clinical Data Management KPS Life - 3.0 San Diego, CA Job Details 14 hours ago Qualifications FDA submissions Statistics Budget management Document review (document control) Clinical study protocols and reports Biostatistics Mathematics Databases 8 years Data quality management Statistical analysis Policy & process development Quality assurance Bachelor's degree Team management Scientific protocols Regulatory submissions Due diligence Budgeting Data validation Bachelor's degree in mathematics Senior level Project leadership Process management Leadership Employee evaluation Regulatory compliance management Full Job Description Opportunity Details On Assignment Associate Director, Clinical Data Management San Diego, CA Position Summary The Associate Director will collaborate with the Data Management team by providing leadership and knowledge. Assists the head of Data Management in directing the design, documentation, testing and implementation of clinical data collection studies, and clinical database reviews in support of company objectives. Ensures that the data management systems are business ready and of appropriate quality to fulfill those objectives. Focuses on the oversight of quality data deliverables within Data Management and projects with Contract Research Organizations (CROs). Primary Responsibilities Participates in the collaboration and coordination with others to design and implement clinical protocols and data collection systems. Assists in identifying and resolving data management issues on assigned studies. Responsible for ensuring data management timelines are met within assigned studies, in-house or outsourced. Provides strategic input into protocol design focused on data management portions. May assist Biostatistics in development/review of Statistical Analysis Plans. Reviews and resolves data discrepancies for standardized data validation systems and procedures, when applicable. Supports data management requirements and deliverables for New Drug Application (NDA)/Marketing Authorization Application (MAA), including integrated databases. Aids in production of quality data deliverables to support regulatory submissions, publications and due diligence activities. Reviews clinical, regulatory and other documents, as needed, to assure data integrity and quality. Oversees projects that have been engaged with CROs, as well leads and manages internal projects. Oversees and manages final data management electronic Trial Master File (eTMF) for assigned studies. Assists with the development of standards and process documentation, including Standard Operating Procedures and Work Instructions. Assures compliance with industry quality standards, guidelines and procedures. Assists in the selection and evaluation of new personnel to ensure the efficient operation of the function. May assist in the career development of Data Management personnel. Position may have direct reports. May assist with input into corporate and department budget process and management. Education and Experience Requires a Bachelor's degree in Life Sciences, Mathematics or related field. Targeting 8 years of progressively responsible experience within the pharmaceutical, biotech or CRO industry. An equivalent combination of relevant education and experience may be considered.