To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.

Job #02374

About our client Our client is the biotech division of a world-leading healthcare company that has developed a reputation for successfully bringing complex products to market in a variety of therapeutic areas. With an experienced clinical team and empowering corporate culture that is focused on the professional development of its employees, this is a great opportunity for the right candidate! Position Location Senior Clinical Data Analyst Thousand Oaks, California Salary Highly competitive package, commensurate with experience Responsibilities 1) Track and manage CRF/DCF, CRF design, CRF flow definition, preparation of data management plan, database setup and validation, ongoing project updates, etc. 2) Participate in project team meetings and partner with Project Team to effectively manage subject data and other project related issues 3) Manage data entry operations and implement electronic central laboratory data transfer 4) Manage study databases through validation, identifying data discrepancies, finalizing resolutions, coding medications and adverse events using electronic dictionaries 5) Transfer data to statistics 6) Apply understanding of FDA and ICH regulations when processing data 7) Collaborate with clinical compliance and training to audit study databases for both internal studies and external studies performed by CROs 8) Manage independent contractors, CROs and central laboratories as needed 9) Recommend processes and technology steps to improve department efficiency and productivity 10) Support the development of standard procedures, guidelines and conventions for data management processes 11) Mentor CDAs Requirements 1) BS in Life or Computer Science or a related area 2) Post graduate courses in specific technical areas (preferred) 3) 3+ years of clinical data management experience in a pharmaceutical, biotech or device industry (does not have to be people mgmt, just data mgmt) 4) Data management plan creation experience 5) Experience in setting up a clinical database, using Oracle 6) Solid knowledge of computer systems on multiple platforms using Oracle relational database management