HI,

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: DESAL00012456

Title: SAS  Clinical Program  Analyst

Location: Alameda, California

Duration: 12 Months+

Rate: $ 45-48/HR (max)

 

Locals Only (On-site work Required)

 

Position Summary from Legacy System

This field includes Main Responsibilities imported from Legacy System.

This position is responsible for implementation of data management
activities in support of clinical trials, including: design and maintenance
of clinical databases using Oracle Clinical or other major Clinical
database, SAS; review of data collection forms; generation of data tables,
listings and reports; establishment and documentation of data management
processes.  Designs, programs, installs and maintains quality databases for
the clinical studies. Provides technical support for assigned databases
responding to database and user problems. Determines causes and resolutions
of problems when they arise to ensure continued operations. Writes user
documentation, functional and technical specification documents. Ensures
data validation specifications are comprehensive, appropriate, and are
created according to the company procedures and requirements. Extracts
clinical study data from the databases and prepares data for statistical
analyses, develops programs to create data listings and summary tables,
provides programming support needed to analyze the data.

 

Additional Main Responsibilities from Legacy System

This field includes Main Responsibilities imported from Legacy System.

Ensure that database design is consistent with 21 CFR part 11.

Provide input to the development of case report forms, in conjunction with
Clinical Research and Clinical Data Specialists.

Annotate CRFs and develop study clinical databases using Oracle Clinical or
other clinical database.

In conjunction with Clinical Data Specialists, write study specific data
entry work instructions.

In conjunction with the Validation team, ensure databases are validated and
data entry training has been provided before the database is activated.

With Clinical Research staff and Clinical Data Specialists, contribute to
the development of data edit check rules.

Program edit checks and provide documentation of data validation checks.

Contribute to Data Management Plan to document study specific data
management activities that will ensure data integrity.

Participate in efforts to standardize, streamline and enhance DM processes,
write SOPs.

Generate data tables, listings, reports, and ad hoc queries from Oracle
Clinical and related databases using SAS or other software tools.

Maintain clinical databases according to change control procedures.

Oversee query generation and resolution and resolve issues with validation
rules.

Provide programming support to the CRAs as needed.

Act as a resource for database related questions.

Prepare and review reports clearly communicating results in a manner
suitable for both technical and nontechnical customers.

Support software requirements including development, maintenance and
validation of software for Clinical Affairs Group as required.

Provide general (statistical) software support to the Clinical Affairs Group
and other departments as required.

Collaborate with company wide groups as and when required.

Provide supervision to staff, including setting direction and goals,
performance reviews and development plans as and when required.

Must be able to tap into appropriate resources when specific expertise is
needed that cannot be achieved individually.

Support relevant training activities, presenting data and results in a
suitable format.

 

Accountability/Scope/Budget from Legacy System

This field includes Accountability/Scope/Budget information imported from
Legacy System.

Support of mission critical Clinical systems Completes given projects on
time, accountable for the project timelines  Clearly communicates with
management and peers   Assumes responsibility for completing individual and
team assignments and tasks         Reliable attendance is required for this
position  Individual contribution should make a measurable difference to the
department and the business.

Works on technical problems of moderate scope where analysis of the system
requires technical expertise.

Exercises judgment to achieve desirable end results.

May work on several technical problems of moderate scope where analysis
requires review of given parameters/systems and strong communication skills.

Exercises judgment within defined procedures and practices to determine
appropriate action.

Adjusts and correlates clinical data, analyzes results, and recognizes and
corrects system bugs.

Performs work using existing standards, methodologies and processes,
investigates alternatives.

Learns new software and supports it.

Understands and applies procedures, practices and department standards to
consistently produce error free results in a timely manner.

Develops project plans and ensures the dates are met.

Independently proposes and develops new programs to handle and analyze
clinical data.

Identifies and implements process improvements.

Aware of other business processes and related disciplines and how they
relate to each other.

Participates in projects as a Clinical programmer.

Makes decisions on the software and internal structure of the Clinical
Database.

Creates database development plans and follows the plan through a series of
related detailed steps to achieve the anticipated goal.

Completes project tasks within time and budget constraints.

Works under general supervision of Manager or Principal Programmer.

Work is reviewed for soundness of judgment and to determine if desired
results have been achieved.

Risks associated with tasks extend to impact on a major study timeline.

Programming expertise is recognized by peers, Clinical group and management.

Directs shortterm activities performed by vendors, or less experienced
peers.

Influences timelines of the studies.

Sells new processes/software solutions/programming practices to management
and peers.

Deals regularly with other members of the Clinical group and managers within
department and vendors.

Will represent database sub-group of DM group on projects or segments of
projects.

 

 

QUALIFICATIONS

Note: This job description is not to be considered an exhaustive statement
of duties, responsibilities or requirements and does not limit the
assignment of additional duties for this role.

 

Additional Qualifications from Legacy System

This field includes Qualifications imported from Legacy System.

Bachelors degree required.  Biostatistics, statistics, information science,
public health, or life science preferred.   Minimum of 3 years experience in
clinical research and database programming; prefer at least 1 year in device
or pharmaceutical clinical trials as a clinical programmer performing
mentioned above functions using SAS, Oracle Clinical or Clintrial
and/orACCESS  Experience building at least one major clinical database
Coordinates and monitors activities/projects  Able to set up, clearly
communicate and follow project plans  Participated in SOP, WI and other
guidelines design  Provides technical support to all the members of the team
Actively participates in activities (teamwork). and makes valued
contribution to multidisciplinary team projects.  Shares resources,
knowledge and accountability, leads others   Must have experience in using
SAS, word processor applications, spreadsheets and databases.  Must be
accurate and organised in work approach and have good attention to detail in
order to ensure that the programs developed meet requirements and are fit
for purpose.  Must have good oral communication skills to be able to provide
management and staff with feedback on performance and development needs and
report and present progress to Senior Management.  Must have good written
communication skills to be able to prepare appropriate reports, interpret
results and prepare effective summaries relative to the implications of
those results.

 

Position ID: DYESFK001855-1

Title: SAP ABAP Technical Analyst

Location: Lake Zurich, IL

Duration: 3 Months+

 

Locals only (onsite work Required)

 

Primary Responsibilities: 

Tasks to be performed by the Sr. SAP Technical Analyst will include, but not
limited to the following: Responsible for the analysis, design, and
development of reports, forms, data interfaces, and custom programming in
the SAP R/3 environment as need to support business requirements. Provides
troubleshooting, support and maintenance of existing developments.
Responsible for analyzing business needs as defined in the functional
specifications provided by the SAP Business Analyst, designing and
developing a solution to meet those needs. When appropriate, proposing
multiple options for a solution along with a corresponding recommendation.
Responsible for creation of technical specifications documenting the
programming details required to support the defined business requirements.
Analyze program performance, and perform necessary tuning to ensure
efficient utilization of system resources. Follows best practices and coding
standards to ensure clarity and maintainability of all custom developments.
Consistently deliver high-quality and timely services to end-users.

 

Skills/Knowledge/Experience Required:

Bachelor's degree or equivalent work experience.5 - 8 years of SAP R/3
programming and workbench skills. 

Experience with SAP Dialog and screen programming. 

Experience with the SAP Enhancement Framework. 

Experience with Web Services / SOAP calls. 

Experience with all MM, SD, WM, FI, CO, PP and PM. 

Experience in BAPI, ALV, LSMW, RFC, SAP Script, SMARTFORMS, and Adobe forms.


Experience with IDOCs, IDOC extensions, ALE and EDI. 

Experience with SAP Solution Manager. 

Strong experience in the full life cycle of the development process,
including requirements definition, prototyping, programming, testing and
implementation required Previous experience with FDA Validation a plus.
Strong written and verbal communication skills.

 

Position ID: DYESFK001850-1

Job title: Instructional designer(ID)  with SME (Subject Matter Expert)

Location: Lake Zurich, IL

Duration: 6 months (contract only)



Locals Only

 

Job Description:

Instructional designer (ID) is required to design and develop learning
experiences in the form of instructional material, training courses, and
multimedia technologies. The ID will work with other departments to
determine what employees need to learn so they can successfully complete all
job functions. In developing learning programs, the ID will determine
learning objectives, rewrite content, structure learning activities, and
create visual aids for both face-to-face and online interactions. The ID
will also develop assessments and adapt existing materials in other formats.
They will work closely with the Subject Matter Experts (SMEs) within the
various business units to ensure that all content not only meets good adult
learning requirements but is also responsive to all regulatory and legal
requirements. The business unit leader is the ultimate customer for the ID.
The ID may also be required to develop customer materials and ensure all
documents successfully complete the Fresenius Kabi regulatory and quality ad
prom processes.

 

PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT.

. Design and develop instructional materials

. Work with subject matter experts to transform technical documents and
information into compelling learning content

. Conduct needs analysis to ensure learning programs are targeted to
participant needs

. Create visual aids for both face to face and online interactions

. Develop assessment tools at all 4 Kirkpatrick levels, especially to
determine if application of learning has taken place in the day to day job
requirements

. Meet regulatory requirements when designing customer facing materials

. Investigate emerging learning technologies to ensure learning materials
meet the needs of adult learners in the most efficient and effective manner

. Employ good project management skills to ensure learning projects are
developed on time and within budget

. Wear multiple hats undertaking the various roles of facilitator,
innovator, researcher and developer with an emphasis on electronic learning
methods

 

 

REQUIREMENTS

. A Bachelor's degree in adult learning, instructional design or related
area

. 3-5 years of experience working in higher education or company training
with, creative problem solving abilities, and facilitation experience.

. Experience of working in a regulated environment, sales process knowledge
and global experience would be an advantage.

. Proven abilities in curriculum development, instructional design and
analyzing and using emerging learning technologies.

. A good working knowledge of Microsoft Office Suite, in particular
PowerPoint and Adobe Articulate (or similar design program).

. Ability to perform quality work within deadlines and work effectively as a
team contributor.

. Interact professionally with other employees, customers and suppliers.

. Work independently while understanding the necessity of communicating and
coordinating work efforts with other employees and organizations.

. Interest in the implementation of innovative, creative course delivery
methods.

. Be willing to take direction from SMEs while at the same time providing
feedback to SMEs regarding good learning design.

Comments for Agencies:    

Shift hours: Mon -Fri 8am to 5pm CST flexible

Work location: Remote but they may need to come into the office for meetings
(someone that can drive to Lake Zurich)

 

Position ID:: DESAL00013118

Job Title- Infrastructure Solutions Engineer (VMware)

Location: Waukegan, IL

Duration: 12 Months+


Locals Preferred


Position is remote; the expectation is for worker to be local so they can
onsite once the COVID restrictions are lifted.

Top Skills

1.) Strong experience with a variety of operating systems protocols
including but not limited to Windows, RedHat and HP UX (current versions) on
physical and virtual machines and associated tools, depending on the type of
platform or application to be administered.

2.) Knowledge of Hyperconverged hardware solutions (i.e. with Dell
Datacenter Server Hardware solutions) as well as rack mount server
infrastructure. 

3.) Familiarity with VMware virtualization technologies 

4.) Knowledge of SDLC

5.) Familiarity with tools used on the various server operating systems
platforms (monitoring/event monitoring, bladelogic)_

 

 

Job Description

Abbott is looking to add a contract Infrastructure Solutions Engineer to
support the activities of the Infrastructure Solutioning team.   Candidate
will work closely with customers, Technical Project Managers, DB architects,
storage engineering, network engineering, cloud intake team and many other
BTS lines of business resources to solution per Abbott standards. This role
will be heavily involved in understanding requirements and
understanding/translating those to Abbott BTS standards to produce the most
efficient infrastructure server solution to meet the customer's needs. This
may include recommending the purchase of infrastructure hardware, obtaining
quotes and determining supplier. May need to coordinate infrastructure
installation with technicians. This is mainly for Windows based platform but
will encounter Linux/Unix platforms as well.  Able to rapidly absorb and
implement new technologies and procedures. Capable of performing tasks in
dynamic/changing situations and, under stress, optimizing availability of
system services to users/LOB staff. Familiar with SDLC methodologies.
Excellent interpersonal and communication skills. Limited understanding of
Database, Web, and Client Server technologies. We service globally across
various time zones and will need to adjust sometimes to accommodate.

 

Qualifications

A Bachelors degree in Computer Science , Engineering, or equivalent work
experience. At least 5 years of experience in infrastructure design
engineering, systems support and working knowledge of specific technology to
be administered. Familiarity with multi-platform environments. 

 

Position ID: DYES00011360

Title: Project Manager Mainstream IV (DII3) - Information Security Risk
Management

Location: North Chicago, IL

Duration: 6 Months+ 

 

Locals Preferred

 

Primary Needs: 

.      Position will reside within the Information Security Risk Management
(ISRM) Team at Client, driving functional continuous improvement projects
aimed at improving strategic and operational capabilities, including
formulating long-term strategy & roadmaps. 

.      Experience in managing Information Security, Governance and
Compliance projects would be beneficial, as this Project Manager will lead a
variety of projects within the following 6 ISRM key workstreams aimed at
driving strategy: 

.         ISRM strategy to address risk 

.         Driving risk accountability 

.         Scaling ISRM capabilities 

.         Continuous improvement processes 

.         ISRM / IAI (Innovation/Architecture/Infrastructure) collaboration 

.         ISRM intake process improvement 

.      Must be a senior level project manager (12+ years of experience) with
a strategic mindset. Note: this position will require experience in managing
strategic projects/focused on strategy. Technical experience within ISRM
projects will be a lower priority for any PM applying. 

.      Will be expected to prepare and present executive level
presentations. 

.      Strong project management skillset, including proven ability to lead
and drive project success. 

.      Strong collaboration and communication skills given the high degrees
of business strategic impact, Senior Executive interactions, and project
complexities, accompanied by a medium degree of change. 

.      Will work with multiple internal Client teams & staff. 

.      Contract to run from candidate's start date through April 30, 2021.
(Extensions possible following proven performance.) 

.      Will execute and deliver in line with below expectations. 

Expectations: 

.      Develop, execute and manage project(s) within the defined scope. 

.      Lead all aspects of the project lifecycle, 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. 

.      The individual will rely on experience and judgment to plan and
accomplish goals. 

.      Performs a variety of tasks. 

.      May lead and direct the work of others. 

.      Be able to work under general supervision. 

.      A certain degree of creativity and latitude is required. 

Specific Responsibilities: 

.      Initiate and Plan Project: Works with business, ISRM and IT
management to establish and gain consensus on project goals, objectives,
financials and deliverables. 

.      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 project 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. 

Qualifications: 

.      PPM Tool experience a must. 

.      Individual must be able to work full time; depending on start date,
may initially work in a remote setting, with transition to on-site in Lake
County. 

.      Primary Needs on page 1, reiterating that this position will require
experience in managing strategic projects and will be focused on strategy.
ISRM Technical experience will be a lower priority for any PM applying 

Preferred Qualifications: 

.      Experience with using Clarity PPM a plus. 

.      Familiarity with Organization Change Management experience/knowledge.


.      Note: no requirement for PMP or Pharma experience. 

 

Thanks & Regard's

Harry John
Dynamic Enterprise Solutions Inc
1801 Hicks Rd, unit A
Rolling Meadows, IL -60008
(847) 719-7902 /C 224-635-0898
Email: ha...@dynamic-enterprise.net

 

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