Must have experience working in Matrixed environments
Identify and implement robust and modern Statistical Computing Environment and Clinical Data Repository with adequate security, trace-ability, version control and complete audit trails of all submission and regulatory related statistical programming activities including creation, modification, deletion, movement, uploading and downloading of data and reports, as well as access provisioning.
• Authoritative repository for all clinical data required for submission; Clinical data spread across multiple systems
• Excessive time spent searching for, gaining access to, and aggregating clinical data from internal and external sources for analysis
• Inefficient collaborative processes, including data exchanges and quality assurance challenges with external vendors
• Constrained flexibility in rapidly expanding and deploying current systems and processes
• Limited ability to support robust data science and visualization, SCE should encompass SAS, R, Python, etc.
• Selection of COTS product aligned to EA guiding principles
• Design and sizing of the environments as well as discovery around the tools to be migrated or re-engineered for the new environment.
• Implementation Lead will work with the client & vendor to ensure the provisioning and deployment activities are planned and managed efficiently.
• Validation will be handled in accordance with the client SOPs and there will be focus on Business Configuration activities which will be a key influence into the UAT strategy and approach.
• Migration will be planned early to ensure that operational activities are well understood, and study milestones are managed in conjunction with submissions upcoming or actively under review
•Solution will be integrated into clinical data ecosystem
• A data migration test will be executed in Production before fully scaled batch releases
**Candidates must be available to work directly on our w2 without sponsorship**