The opportunity
The Clinical Programming Senior Manager is responsible for managing the timely and accurate execution of programming components of clinical trials.
The Senior Manager leads and manages completed projects that involve global tasks, cross functional teams, or outsourcing resources. The role may require providing inputs to design and analysis, and reporting the results of clinical trials, including programming rules and mocked T/L/G. In addition, providing all safety claims for new drugs and extension of claims/publication support for our marketed drugs.
How you’ll spend your day
Primarily works at the product / program level
Possible to have direct reports; Likely to oversee contingent workers and/or vendors; likely to provide training to others; Analyzes needs to manage resources
Provides input for Budget Planning
Manages and Delivers assignments with quality and within timelines
Provides strong programming support to CDISC based e-submission. Develop, review, and/or perform validation of generic macros Develop, debug, and enhance SAS programs to support quality control of safety or efficacy derived datasets.
Implement programming standards and comply with regulatory requirements among project team members and across all projects; communicate to management on project status and resource issues.
Responsible for the standardization of GSD deliverables
across study projects within an indication/therapeutic area.
Responsible for the overall definition of programming rules and standardization across therapeutic areas and/or indication.
Leads global projects with cross-functional involvement; demonstrate project management and leadership capabilities.
