Hope you are doing great!

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)


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
*       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
*       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
*       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

*       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
*       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.



*       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
*       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
*       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 



*       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



*       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
*       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
*       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
*       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
*       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.


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
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.
To view this discussion on the web visit 

Reply via email to