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

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.

Senior Clinical Programmer – SDTM

Key skills