This job board retrieves part of its jobs from: Customer Service Jobs | Fort Saskatchewan Jobs | Work From Home

The only website bringing offers to health care workers!

To post a job, login or create an account |  Post a Job

Senior manager clinical it systems cambridge

E. Holdings, Inc.

This is a Full-time position in Cambridge, MA posted May 29, 2019.

 The Senior Manager, Clinical IT Systems will lead application development, support, maintenance, and computer system validation (CSV) activities for all Clinical Operations and Research & Development related systems.

This employee works with the Business Architect, Clinical and business stakeholders to translate business requirements and processes into a solution architecture best suited for Kadmon’s future.

This position must provide industry knowledge of the technical aspects of clinical systems, including, but no limited to, EDC, eTMF, CTMS, LIMS, ELN and EDMS.

This employee will also be accountable for system administrative and change management functions for these applications.Key : Lead all software architecture considerations for Kadmon’s Clinical and R&D systems.Lead computer systems validation activities for validated systems, produce appropriate documentation and deliverables, and ensure processes are followed.Manage the application roadmaps for Clinical and R&D systems.Manage intake process for all service requests related to Clinical and R&D systems.Accountable for administration of Clinical and R&D systems.Accountable for creation and maintenance of all necessary administration documentation, providing appropriate backup knowledge for other team members and Tier1 helpdesk support.Engage with various managed services teams to organize, prioritize, and track technical deliverables and SLAs.Assist with extracting business requirements from internal and external customers and translate into technical requirements and specifications.Own all change management for Clinical and R&D systems in appropriate validated tracking software.Additional : Partner with other IT team members to build CSV strategy and documentation for various application projectsUse Business Analysis and/or Project Management skills when required to drive engagements to successful completion.Facilitate scalable data collection and reporting from Clinical and R&D systems: B.S.

or M.S.

in a technical field7+ years configuring/supporting Clinical and R&D systems in Biotech or PharmaStrong experience and training in computer system validation processes and authoring documentationITIL experience preferredTechnical knowledge of Clinical and R&D business processes includingo Clinical Trial Managemento Data Managemento Electronic Document Management in a regulated environmento Electronic Trial Master Fileo Electronic Regulatory Submissionso Safety and Pharmacovigilanceo Study Startup and BudgetingExperience in life sciences, biotechnology, and/or food industries requiredExcellent organization, written and oral communication, and management skills