• Provide Validation/QC guidance in regards to clinical data programming tasks for multiple studies.
• Provide Validation/QC support for study team members from the study start up to the end.
• Review/Provide Validation QC support for the database, data transfer, SDTM mapping specs to ensure that documents and specification are consistent and comply with internal/industry standards.
• Perform data reconciliation, data quality control, and program SAS edit checks..
• Review/generate/validate electronic submission deliverables such as SDTM datasets,
• Perform Quality Testing/User Acceptance Testing of EDC systems.
• Support quality control and quality audit of deliverables.
• Contribute to activities for validation/QC and implementation including standard reporting systems, SAS macro utility programs and associated tools.
Responsible for maintaining a formal quality control process in accordance with Clients standard operating procedures and Good Clinical Practice.
Perform validation & quality control to ensure all program development activities within the Oncology Business Group IODS 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 IODS group
1. Work closely with the data management team members to coordinate and execute validation and QC activities
2. Evaluate system/study level validation/QC activities along with drafting of supporting documentation
3. Oversee testing and validation/QC activities of existing clinical studies
4. 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 trails
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
Source: Job Diva – Job Listing