- Review and provide input into all trial set-up documentation
- Translate protocol and any applicable de-risking into the creation and maintenance of detailed technical specifications, mapping documentation including aCRF, data transfer agreements, as applicable, etc.
- Creation of Data Review Model (DRM) based on current Client standards and SDTM datasets based on current SDTM standards
- Creation of back-end edit checks, listings, and visualizations to support risk-based central monitoring, e.g., Quality Tolerance Limits (QTLs), Critical to Quality (CtQ), etc., and ongoing clinical and safety data review
- QC of all clinical programming deliverables
- Perform unblinding, data-cut activities for planned reporting milestones and database locks
- Development and validation of electronic submission packages that comply with submission requirements from FDA, EMEA, and other regulatory agencies as needed.
- Support the development of standards and drive implementation within the organization
Experience
- Minimum 4+ years of relevant experience in SDTM Clinical Programming
- Good knowledge of data structures and relevant programming languages for data manipulation and reporting (i.e., SAS, SQL, Python, R, etc.)
- Strong knowledge of complex finding data types, including but not limited to biomarkers, and digital data such as ECG, imaging, etc.
- Advanced knowledge of SDTM including Define.xml, CDASH, and metadata as well as experience transforming transferred vendor data into SDTM preferred, knowledge of ADaM a plus
- Demonstrated understanding of current industry standards for submission of clinical trial data.
- Demonstrated organizational and leadership skills to handle multiple competing priorities simultaneously across projects.
- Ability to communicate with cross-functional teams, and business partners and gather feedback for study specifications and/or data issues.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
