Senior IT Quality Validation ConsultantMonday, April 1st, 2019
Senior IT Quality Validation Consultant
Contract Term: Anticipated 1 year
Location: Bergen County NJ
Responsible for maintaining a formal quality control process in accordance with Client’s standard operating procedures and Good Clinical Practice. Perform validation & quality control to ensure all program development activities within the Oncology Business Group follow established processes, and ensure proper documentation and timely posting into the TMF as required.
This includes but not limited to the validation and QC support of clinical database design, reports & listings programs, SDTM conversion and related programming, post production changes, and implementation of programming tools within the group
- Work closely with the data management team members to coordinate and execute validation and QC activities
- Evaluate system/study level validation/QC activities along with drafting of supporting documentation
- Oversee testing and validation/QC activities of existing clinical studies
- Collaborate with Regulatory and Publishing for submission activities
- Bachelor or higher degree in Computer Science, Engineering or related field;
- Minimum 5 years’ experience in the areas of software development life cycle supporting a GCP environment, clinical database set up in the pharmaceutical or related industries, clinical data management process and a practical understanding of GCP validation requirements
- Aware of FDA, EMA, MHRA and ICH regulations and guidelines governing the conduct of clinical trials
- Understanding of EDC systems, such as Medidata Rave, Inform, OC-RDC, IXRS (IRT), or other similar applications
- Excellent oral and written communication skills; good “people” skills, good organizational skills to effectively guide multiple resources involved in various projects.
- Excellent team player; able to work under pressure, handle situation involving different functions and teams