Clinical Systems administrator - Sharepoint

Saama Technologies Inc - Sunnyvale, CA3.5

The Clinical Systems administrator will plan, configure, deploy, and support Clinical systems including Clinical Trial Management System (CTMS), Electronic Trial Master File (eTMF) and other enterprise systems supporting core R&D functions and processes. The resource will be hands-on and will collaborate closely with Clinical Operations, other R&D departments, other IT resources and our SaaS vendors. The position will work closely with the IT Clinical Architect and will report directly to the Manager, IT R&D Clinical Applications.

Key Accountabilities/Core Job Responsibilities:
Overseeing administration of Clinical systems, including user access, maintaining permissions/roles
Administering SharePoint (2010-2016)

Working with Super Users to:
Efficiently enter data and ensure data quality
Investigate system issues, performing root cause analysis
Evaluate options for system enhancements/process improvements
Planning/implementing incoming integrations with IRTs, EDCs, CROs, etc.
Planning/implementing downstream uses of CTMS data (e.g., reporting and feeding other business processes)
Planning/implementing reports/graphs/dashboards (Excel, SSRS, Tableau, Business Objects, etc.)
Evaluating requests for customization using various platforms/technologies (SharePoint, InfoPath, HTML, CSS, XML, JS, Office automation)
Using Microsoft Excel and other tools to analyze/process clinical operations data
Collaborating with the Business Owner, System Owner, IT Compliance, etc. to drive Change Control for Clinical GxP applications
Lead impact analysis and system testing for new releases/patches
Proposing validation strategy, authoring SOPs/validation protocols/test plans, etc.
Assisting in the creation of training materials/programs
Leading in meetings with Business customers and assisting the Project Manager in generation and management of documents and reports

Qualifications, Experience, and Education Requirements:
Deep understanding of operational aspects of a Clinical Trial (Study) including:
Types and Phases of Trials, randomization, requirements for single/double blinding, etc.
Analyzing Study Protocols to extract operational information
The purpose of IRTs and what data should be integrated with CTMS
The purpose of EDCs and what data should be integrated with CTMS
Milestones at Study, Region and Site level
Risk-Based Monitoring
The purpose and process of issues/protocol deviations
The purpose and process of Serious Adverse Events (e.g. safety reporting portal)
Regulatory requirements for Clinical Trials (especially in US but also familiar with worldwide differences)
Clinical Payment systems

Deep understanding of IT practices including:
Computer Systems Validation
GCP/GVP/GDP/ICH and Title 21 CFR Part 11
Change Control for GxP systems
Using helpdesk/ticketing systems (especially ServiceNow)
Good speaking/written communication skills
Prefer 5+ years relevant IT experience

Knowledge of the following is preferred:
VBA/MS Office Automation, Customization and Interoperability
PowerShell scripting
Database Design and Management (especially T-SQL/Oracle)
Data warehousing and ETL (especially Informatica and Oracle)
SharePoint Development (non-code)
InfoPath Development
Web technologies, e.g., HTML, CSS, Java[Script], JSON, Web Services/REST, XML/XSLT
Visual Studio/.Net development
Microsoft Office, including: Access, Word, Excel, PowerPoint, Outlook, Project