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This is Harry from Dynamic Enterprise Solutions. We have urgent requirement with one of our client's, please review below job description and let me know your interest Position ID: DYES00006711 Title: QA Systems Administrator/Operations Analyst Location: Sunnyvale, CA Duration: 12 Months+ Locals Only (Phone and in person) Description: General Position Summary/Purpose: The QA Systems Administrator/Operations Analyst will plan, configure, deploy, and support QA and GMA systems including Information Request Management System (IRMS), Interactive Voice Response System (IVRS), Quality Management Systems (QMS), Trainings applications and other enterprise systems supporting core R&D functions and processes. The resource will be hands-on and will collaborate closely with Quality Operations, GMA and other R&D departments, other IT resources and our vendors. The position will work closely with the IT Operations and will report directly to the Manager, IT R&D Regulatory and QA Key Accountabilities/Core Job Responsibilities: * Overseeing administration of Quality and GMA 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 CROs, third party vendors, CIS, etc. * 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 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 Manufacturing and Medical Affairs including: * Quality documentation and management * Audits and submissions to FDA and other health agencies * Process management for filing AE, Product complaints, etc. * IVRS call center workflow and call forwarding rules * Case report review and processing * Risk-Based Monitoring * The purpose and process of issues/protocol deviations * Regulatory requirements for Clinical Trials (especially in US but also familiar with worldwide health agencies) * 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 * Are you open to look at candidates willing to relocate? * Preferred local * Years of experience/education/certifcations required: * 5+ years and bachelors degree * What are the top 3 skills/requirements this person should have? * Business Analyst Skills * Data Migrations * Expert level in MS Excel * Soft Skills? * Organization * Communciation * Interview Process (will this be a phone or in-person interview): * Phone and in person Position ID: DYES00006781 Title: Sr. IT R&D Project Manager Location: Sunnyvale, California Duration : 6 months but can extend to full 18 months Locals only (Phone and In Person) Job Description This role will be responsible for managing GxP projects involving computerized system validation (CSV) and 21 CFR Part 11 across the QA, clinical, regulatory, and laboratory areas. Ability to develop relationships with R&D stakeholders, solicit, define, and document project requirements, and fluidly working with IT technical contributors. This role demands a strong hands-on PM with excellent track record of accomplishment of managing multiple projects and leading with authority. This role will have a vested interest in meeting all milestones and will work with external vendors, technical leads, validation team, and the business in order to accomplish the greater goals of the project on time and within budget. Key Accountabilities/Core Job Responsibilities: * Pro-actively lead requirement gathering efforts and coordinate with business SMEs, IT architect, IT Business Analysts, Developers, Validation Team to translate information into Functional and Technical requirements specifications. * Independently coordinate with Vendor and in-house Programmer/Administrator staff * Author project documentation including Business Justification, Project Proposal, Project Charters, Budget Tracker, Schedule, Status Dashboard, Timeline visuals, Lessons Learned * Professionally prepare presentations for IT, Business stakeholders, provide roadmaps, strategize project roadmap * Maintain organized, clear, focused project status, schedule to ensure project success. * Manage Vendor relationships and lead calls with vendors * Ensure GxP validated solutions comply with FDA regulations throughout the solution lifecycle, working tightly with internal PCYC IT Validation SMEs/Team, Quality. * Escalate issues to Sr. Management, and to vendor support as needed Qualifications, Experience and Education Requirements: * 5-7 years of experience managing projects to implement system/s in GxP controlled environment including responsibility for the implementation of R&D systems * Strong interpersonal and communication skills; ability to interact with different levels of management. * Project management in the Bio-Pharma, Life Sciences industry is required. * Skills: Project Management, SDLC, Business Analysis, Vendor Management, Computer Systems Validation. * Proficiency in Microsoft Office applications, including PowerPoint. * Pharma systems experience in QA, clinical, labs, and/or regulatory is a plus. * BA or BS degree in technical or scientific discipline required. * PMP certification. * Years of experience/education/certifications required: * Bachelors in Business/Marketing/Communications * What are the top 3 skills/requirements this person should have? * GXP Experience * Familiar with R&D systems (clinical or Laboratory) Position ID: DYES00006780 Title: Project Manager requirement for Veeva Study Startup Utility (SSU) Location: North Chicago, IL Duration: 6 Months+ Locals Only (Phone and In Person) Must Have Veeva Study Startup Utility Primary Function: Develop, execute and manage large, more complex IT project(s) within the defined scope. Manage a multitude of interrelated project activities and lead all aspects of the project life-cycle, working with project sponsors/key stakeholders, team members, and management to oversee all phases of project completion. Build and manage project's work breakdown structure, milestones, risks, issues, and deliverables within the constraints of human and financial resources and changing priorities to ensure the successful completion of the project. Ensure transparent reporting of project status, issues, risks, and financials. Key Responsibilities: * Initiate and Plan Project: Works with business and IT management to establish and gain consensus on project goals, objectives, financials and deliverables. Responsible for building the plan and resource needs to accomplish the scope. * Project Control: Assess the degree to which changes to scope, issues and risks will affect the project working with business and IT management and sponsor to gain agreement for resolution. Measure performance to assure the project is progressing as compared to original plan and budget. * Executing and Closing Project: Develops and executes a work plan obtaining authorized resources to ensure all activities are performed. Leads team in delivering project scope. Gather lessons learned and obtain final project approval from sponsor and stakeholders. * Project Communication: Communicate project progress by producing project reports to provide timely and accurate program status and decision support information to project teams, business, and IT management. Makes recommendations based on current project status to resolve issues and manage risks. * Resource and Team Management: Coordinate resources to ensure project needs are addressed and effectively assign tasks and deliverables to team members based upon their abilities. Motivates project team in order to deliver project outcomes. * Quality Management: Responsible for compliance with applicable Corporate and functional policies and procedures. * Decisions: Make decisions that impact project level activities. Influences or has final decision authority for project budget. * Financial Control: Develops and manages a large financial plan with multi-million dollar spend over two years. Tracks actual spend, accruals, proactively creates spend estimates on a regular basis (at least monthly) and coordinates estimates and invoices with project vendors, in order to maintain spend at +/- 10% of the overall project budget. Qualifications: * Bachelor's degree in business, Information Systems/Computer Science or related discipline. * Demonstrated experience in managing projects of various types. * Proven Microsoft Project, PowerPoint, Excel, and Word skills are required. * At least 6 years' experience in project management, business systems analysis, or software development * Individual must be able to work full time on-site Preferred Qualifications: * PMP Certification * PPM Tool experience * Pharmaceutical experience * Regulatory Affairs experience * Experience managing SDLC projects * Experience with Data migration projects. Key Stakeholders: * Business and Technology resources; varying levels of leadership * Years of experience/education/certifications required:- * Bachelor's degree in business, Information Systems/Computer Science or related discipline * What are the top 3 skills/requirements this person should have? * As taken from the Qualification Section in the Job Description: * Demonstrated experience in managing projects of various types. * Proven Microsoft Project, PowerPoint, Excel, and Word skills are required. * At least 6 years' experience in project management, business systems analysis, or software development Position ID: DYES00006791 Title: Java Technical Lead with AWS (DYES00006791) Location: North Chicago, IL Duration: 12-18 Months+ Locals Preferred Experience working with Commercial Off-the-Shelf (COTS) products. Experience of implementing and deploying COTS software. COTS is Commercially off the shelf, in other way packaged software by providers like Salesforce.com, Workday, Veeva etc Description: * Required: Technologies/Working Knowledge: n-tier application architecture, COTS (vendor application) and SaaS models with interfaces; web service integration; solid understanding of a programming/scripting language (e.g., Java). * Experience working with and applying best practice design patterns for system integrations. Strong ability to analyze overall architecture of systems, including hardware and software requirements, and identify solutions for solving technical problems. Knowledge of different database types, (e.g. relational, NoSQL, and distributed storage environments. * Continuous Integration/Continuous Development (Development Operations) methods. * Cloud services (Amazon Web Services, Azure) methods/capabilities, including container technologies. * Experience working with Commercial Off-the-Shelf (COTS) products. Experience of implementing and deploying COTS software Requirements: * Senior technical lead and principal designer for application development or package selection and implementation efforts. * Provides comprehensive consultation to business units and IT management and staff at the highest technical level on all phases of application programming and process implementation for diverse development platforms, computing environments (e.g. host based, distributed systems, client server, software, hardware, technologies and tools, etc.). * Responsible for translating functional specifications into application design specifications, including but not limited to the creation of application architectures, hardware and software configuration specifications, relational database schemas, and component/class specifications. * Interact closely with the Business Systems Analysts, the client user community, and IT management and staff to identify technical solutions, or a combination of available alternatives. * Coordinates and facilitates application design sessions with development staff. * Reviews all technical aspects of a software implementation effort, including the monitoring of technical deliverables for consistency and quality. * At least eight, typically ten or more years of solid, diverse work experience in IT with a minimum of six year experience in application development using structured methodologies, or its equivalent in education and work experience (total combined experience 8 -12 years). * Requires in-depth knowledge of systems development life cycle, client area's functions and systems, and technological alternatives in application design and development. * Must be competent to work at the highest level of all phases of system modeling and implementation. * Requires excellent communication skills, analytical ability, leadership skills, judgment and the ability to work effectively with client and IT management and staff. * Demonstrate proactive, positive, and open communication to promote a productive, team-oriented work environment * Execute all assigned project tasks and responsibilities with consideration to the quality, completeness, and timeliness of all activities and deliverables. * Modify behavior and priorities to respond effectively to changes in work environment or assigned activities. * Understand the current and future business process. * Lead the design and development of technical work products and provide technical direction in all phases and streams of activity within the project lifecycle. * Think globally to ensure the overall technical solution integrity and vision for the project, considering new possibilities for technical solutions. * Follow appropriate Client's standards, processes and procedures, industry best practices (i.e., system architecture designs, and technical "sphere of influence".) * Experience in making presentations Additional Notes: * The candidate needs to be proficient with the Java programming language and with how Java-based applications are designed. A majority of applications we deploy are written in the Java language, so this is a requirement. * Additionally, a majority of the server-side operating environment is the Linux operating system, so being proficient with Linux at a basic-to-intermediate level is a requirement. Java deployed on Linux is a very common application paradigm we see. * From a coding point of view, the candidate will do very little Java coding themselves, but will need to interface with developers who are doing the coding and will also need to conduct code reviews. So, at least an intermediate level understanding of the Java programming environment (and not just the language) is required. * If the candidate does do any coding work, it will be in a scripting language like Python or Javascript, so proficiency in any scripting language (Python, Javascript, Ruby, Perl, PHP, etc.) is a nice to have skill. * We do see applications written in the Microsoft development environment (Windows OS, .Net framework, C#/VisualBasic language, etc.), so being conceptually familiar with the Microsoft environment is a strong nice to have skill * We are increasingly deploying to cloud-based infrastructure, so knowledge of the cloud and what it means to have 'infrastructure-as-code' is a strong preferred (almost required) skill. By the next year, this will be a required skill at Client's. * Expectation that a candidate will be able to follow Client's standards, processes and procedures if he/she is hired. * We are looking for candidates that have experience, in general, with software development and deployment lifecycle experience. It does not need to be specific to Client's SLC process. * This is a preferred skill and not a required skill, however, any experienced technical lead or architect candidate should have knowledge of software lifecycle concepts. * Additionally, we are increasing adopting automated ways to manage and deploy software and understanding DevOps capabilities and technologies and how it relates to software lifecycles is a preferred skill * At Client's, most of our work is solution architecture work. We do very little application architecture work. So, ideally, we would like to see candidates that have stronger solution architecture experience over application architecture experience. * With solution architecture, the candidate should be proficient with the leading application integration concepts and be able to create detailed system integration designs. * What are the top 3 skills needed in the resume? . * technical skills, * problem solving skills and * written and verbal communication skills * Will you use these keywords to search/filter through resume? Here is a starting list: Java, J2EE, Tomcat, Weblogic, Linux, cloud, AWS, Azure, software lifecycle, problem solving, communication skills, devops, system integration, REST, SOAP, Web Services. INTAKE NOTES: Must have : experience on system development, configuration, implementation and support. Ability to modify/develop applications written in .NET and/or Java Minimum 3 years of experience in designing and implementing integration solutions. Technologies/Working Knowledge: Web Service integration; Oracle database; Thanks & Regards Harry John Business Development Manager Dynamic Enterprise Solutions Inc 1801 Hicks Rd, unit A Rolling Meadows, IL -60008 Phone: (847) 719-7902 / (847) 874-7274 Cell: 224-635-0898 Email: <mailto:ha...@dynamic-enterprise.net> ha...@dynamic-enterprise.net URL: http// <http://www.dynamic-enterprise.net/> www.dynamic-enterrise.net -- You received this message because you are subscribed to "rtc-linux". Membership options at http://groups.google.com/group/rtc-linux . Please read http://groups.google.com/group/rtc-linux/web/checklist before submitting a driver. --- You received this message because you are subscribed to the Google Groups "rtc-linux" group. To unsubscribe from this group and stop receiving emails from it, send an email to rtc-linux+unsubscr...@googlegroups.com. 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