Accountable for Validation & Quality Control of all the Oncology clinical study databases build and programming within Data Operations in Oncology PCU. This includes establishment and management of formal quality control process and validation for : standard libraries development and maintenance, clinical database design, reports & listings programs, SDTM conversion and related programming, post production changes, and implementation of different tools. Ensures all the program development activities follow established SDLC methodologies and all the validation activities and processes performed in accordance to the standard operating procedures and GCP guidelines.
• Set up and coordinate quality control activities related to oncology trials database development and maintenance for EDC studies.
• Prepare specification documents, Plans, Test scripts, Summary reports for all areas of programming.
• Conduct tester training and coordinate testing efforts in terms of quality and user acceptance.
• Manage study specific validation documents within Data Operations area. Ensure data quality for deliverables and Regulatory submissions.
• Ensure the data and documents quality for all major deliverables including Regulatory submissions for reponsible areas of Data Services Department.
• Ensure all validation activities and processes performed are conducted according to standard operating procedures and GCP guidelines.
• Ensure all the tools and programs are developed using standard SDLC methodologies and established standards.
• Perform risk assessments and enhance departmental process.
QUALIFICATIONS AND EXPERIENCE:
• Strong experience in clinical study database validation, computer system validation, knowledge of system design life cycle, and the change control process within regulated environment
• Experience in writing validation documents: Functional and User Requirement Specifications, Validation plan, IQ/OQ/PQ Test plans and test scripts, Unit and Integration test scripts, UAT scripts, Traceability metrics, Validation Summary Reports
• Strong knowledge of GCP, 21 CFR Part 11, and guidelines related to different Regulatory authorities
• Experience in writing SOPs, documentation guidelines, and other process documents.
• Knowledge in the areas of programming, clinical database set up, software applications development/ support in the pharmaceutical or related industries is a plus.
• Knowledge of Clinical Data Management Systems and Clinical Data Management process is desirable; Relational Databases: ORACLE; Dictionaries: MedDRA, WHODRUG; Standards: CDISC, CDASH, SDTM.
• Familiarity with InForm, SAS, J-Review is a plus
• Knowledge of EDC systems, eCRFs, edits checks, external data handling, medical coding, listings and reports.
• Excellent oral and written communication skills; good organizational skills to manage multiple projects simultaneously.
EDUCATION GUIDELINES : BS/MS in relevant field
CORE EXPERIENCES: Experience in Data Operations methods and processes in industry setting required.
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