Senior Manager, Clinical Software/Data Diagnostic Hybrids
THIS JOB HAS EXPIRED Category: Clinical/Regulatory
Perform Data Extraction and analysis of Clinical test files using C-DAS/Q-DAT or other applicable programs, may include writing software for data extraction, and analysis.
Develop Clinical Data Management Systems (CDMS) department from current level to a system with automated electronic data checks, 21CFR part 11 compliant, and a team that can meet the high standards for data quality and work efficiency to meet the growing needs of Quidel?s Clinical Research and Regulatory submissions.
Develop and/or oversee acquisition/contractual resourcing of Electronic Trial Master File Systems (eTMF), and Electronic Data Capture (EDC), and Clinical Trial Management System (CTMS) for use in clinical trials. Establish and maintain company standards for case report forms, data entry screens, and edit checks for data acquisition.
Manage and implement rigorous validation procedures for CDMS and Clinical Research data acquisition for both paper-source and electronic-source via wireless/web-based technology. Set-up and maintain Clinical Sofia wireless network for clinical site data transmissions and retrievals from Cloud technology.
Interface with Contract Research Organizations (CROs) and contractors including vendor selection, review of contracts and ongoing evaluation of deliverables in collaboration with Clinical Affairs.
Education and Experience:
Minimum of M.S./M.A. required, preferably in Engineering or Science and a minimum of 8+ years of relevant experience in a pharmaceutical or medical device environment.
Experience with instrument communication, data acquisition and data analysis to include:
Writing software for data extraction, analysis and presentation
Writing software for communicating with instrumentation
Statistical methods and experimental design
Microsoft Office products
Microsoft Access and Sequel Server Express database software preferred
Experience in software product development and testing.
Experience with scientific research procedures, processes, data and statistical analysis.
Experience in development of medical/diagnostic devices and/or fluorescent technology preferred.
Strong organization skills and the ability to manage multiple tasks.
Strong analytical and problem solving skills.
Knowledge of related quality systems regulations and processes.
Excellent communication skills, written and verbal.
Strong leadership skills and the ability to foster strong interpersonal relationships between groups.
Location San Diego , CA
Minimum Experience (yrs):
Required Education: Not Specified
||San Diego, CA |
THIS JOB HAS EXPIRED