CMK Select is seeking to hire a Validation Lead to support one of our pharmaceutical clients in Bergen County, NJ. The Validation Lead will be responsible for establishing and managing a formal quality control process. The Validation Lead will support the Associate Director of Validation and QC to contribute to the establishment and managing of a formal quality control process in accordance with SDLC methodologies. The candidate will perform Validation Quality Control to ensure all program development activities within Oncology Business Group follow established processes and ensure proper documentation and timely posting into TMF system as required. This includes but not limited to the validation and QC support of the development of clinical database design, reports listings programs, SDTM conversion and related programming, post production changes, and implementation of programming tools within IODS Essential Functions Perform Validation and QC under GxP guidelines Review to ensure proper documentation for timely posting in TMF Collaborate with Regulatory and Publishing for submission activities Collaborate with IODS team on Clinical projects Collaborate with CQA and Committee on Policy and Standards Support the development of quality control process Job Qualifications Bachelor or higher degree in Computer Science, Engineering or related field Minimum 5 years experience in the areas of Development Life Cycle and regulatory requirement in programming, Software applications, clinical database set up in the pharmaceutical or related industries, Clinical Data Management process, FDA regulations, system validation methodologies, and test scripts. Good knowledge in TMF. Excellent oral and written communication skills good people skills, good organizational skills to effectively manage and guide multiple resources involved in various projects. Excellent team player able to work under pressure, handle situation involving different functions and teams CMK Select offers MedicalDentalVision Benefits Coverage, Paid Holidays, Paid Time Off, 401k and Generous Salaries. Associated topics: aseptic technique, cytometry, dietetic, health, histotechnologist, immunoassay, kinesiology, medicine, pharmacology, virus
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