Manager in PwC's Software and Product Innovation team leading the development of software solutions and managing talented developers. Responsible for project delivery, team development, and embracing innovative technologies.
About the role
- Senior Clinical Programmer at IQVIA managing SDTM Clinical Programming tasks, including data review model creation and supporting compliance with regulatory requirements.
Responsibilities
- 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
- 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)
- 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.
Requirements
- Minimum 6+ years of relevant experience in SDTM Clinical Programming
- Advanced knowledge of data structures and relevant programming languages for data manipulation and reporting (i.e., SAS, SQL, Python, R)
- Strong knowledge of complex finding data types, including but not limited to biomarkers, and digital data such as ECG, imaging
- Advanced knowledge of SDTM including Define.xml, CDASH, and metadata as well as experience transforming transferred vendor data into SDTM
- 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.
Benefits
- Health insurance
- Retirement plans
- Paid time off
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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