Job title: Senior IT Analyst, Strategic Resourcing
Office-based / Home-based: flexible
Contract / Permanent: Permanent
Join an industry-changing company that is reinventing the way we develop and commercialize drugs. At INC Research/inVentiv Health our 22,000 employees have one purpose: shortening the distance from lab to life. You’ll work alongside the brightest minds to create better, faster, smarter processes to speed therapies to patients that need them the most. In fact, in a recent five-year period, INC Research/inVentiv Health has helped to develop or commercialize at least 82% of novel new drugs approved by the FDA and at least 70% of products granted marketing authorization by the EMA.
Work Here. Matters Everywhere.
We are currently hiring a “Senior IT Analyst” to join our expanding organization and work with Bayer HealthCare, one of the world’s foremost innovators in the field of pharmaceutical and medical products.
INC Research / inVentiv Health and Bayer have a strategic partnership in biometrics that is well-established and global in scope. Within this partnership, you will work as an integral part of the global IT team and focus on the support of the IT infrastructure and clinical data systems.
• Provide strategic technical recommendations in support of initiatives and analyze system requirements
• Responsible for developing, implementing, validating, maintaining, supporting computerized systems in order to ensure that operations are running smoothly within the division, all while complying with internal procedures and meeting established timeframes
• Manage and coordinate the writing and execution of validation protocols, specifications, change controls and/or scripts related to software, instruments and/or equipment according to the organization's user requirements and industry regulation
• Assist internal clients with requests and problem resolution, participate in the maintenance of documentation and make recommendations for greater effectiveness in functional area
• Participate or lead development and/or integration efforts
• Act as a technical resource to other groups
• Contact external consultants and suppliers concerning the development, validation, support and maintenance of the division's applications
• Administrate the division's applications according to the evolution of operational needs
• Analyze, develop and/or implement appropriate desktop solutions for users, in order to respond to identified needs
• Review/harmonize the divisions' work processes and those of other divisions when applicable
• Participate in evaluating and purchasing new systems for the division
• Make recommendations for greater effectiveness of functional area
• Change request creation, analysis of the change, risk assessment, contribute to project and change implementation according to GAMP 5. Creation of deliverables according to GSOP 003 – GSOP 006, document management in Document Management System, (setup workflows, upload documents, actively keeping track of workflow completions, being able to communicate to involved stakeholders).
• Analyzing internal user feedback or update releases from vendors doing the analysis based on internal process what is an applicable change and working on next steps to initiate and complete change request.
• Support with authoring of CSV relevant documentations, such as user requirement specification, validation plan, test scripts and test reports.
• Interact with business application leads, Process Owner Representatives and System Owners/Application Managers and participate in Clinical Information Technology projects.
• Provide technical and business user expertise for clinical processes such as:
o clinical data management & coding
o randomization and statistical analysis
o clinical data acquisition
o clinical data review and visualization methods.
• Several years of IT application business analysis experience, preferably Pharma or Healthcare related
• Several years of experiences with profound knowledge and understanding of Computerized System Validation
• Several years of experience in clinical trials related area, data management and electronic data capture experience, medical coding, randomization and statistical analysis is preferred
• IT application implementation and change management experience is preferred
• Strong IT acumen, technical background and knowledge of system validation, migration and related system documentation principles is preferred
• Technical Knowledge and Understanding of Clinical Data Warehouses, EDC systems, Statistical Analysis programming environments/requirements is preferred
• Strong Communication Skills
• Excellent English skills both written and spoken
In return we will offer:
• A competitive remuneration package with excellent benefits.
• A commitment to your development and training, with the opportunity to progress your career within a market leading and innovative organization.
• The opportunity to work within a successful and rewarding environment.
Please contact Lyndsey Jewitt, EMEA Recruiter at email@example.com for further information. We look forward to receiving your application.